Single Institutional Review Board (sIRB) Implementation Guide
1.0.0 - trial-use

Single Institutional Review Board (sIRB) Implementation Guide, published by HL7 International - BR&R Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0). This version is based on the current content of https://github.com/HL7/fhir-sirb/ and changes regularly. See the Directory of published versions

## : Adverse Medical Event Questionnaire - XML Representation

Draft as of 2023-04-24

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    <Questionnaire xmlns="http://hl7.org/fhir">
      <id value="sirb-adverse-event-questionnaire-populate"/>
      <text>
        <status value="generated"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><b>Structure</b><table border="1" cellpadding="0" cellspacing="0" style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 2px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="The linkId for the item">LinkId</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Text for the item">Text</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Minimum and Maximum # of times the the itemcan appear in the instance">Cardinality</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="The type of the item">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Other attributes of the item">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Additional information about the item">Description &amp; Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_q_root.gif" alt="." style="background-color: white; background-color: inherit" title="QuestionnaireRoot" class="hierarchy"/> AE_Questionnaire</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate#1.0.0</td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Research Study</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae1.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae1.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Title</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae1.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Short title of the study, the same title listed on the Informed Consent</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae1.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae1.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IRB Protocol Number</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae1.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Number assigned by IRB; this number is the same as that on the Consent Form</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae1.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Type</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.3">2 options</a><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae1.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae1.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Does this protocol require an FDA exemption?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.4">2 options</a><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae1.4_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator for use of FDA regulated product</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae1.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is an IND or IDE being used in this study?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.5">2 options</a><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae1.5_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae1.6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae1.5">mae1.5</a> = Yes (expandedYes-NoIndicator#Y)</span><br/>Options: <a href="#opt-item.mae1.6">2 options</a><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" id="item.mae1.7" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae1.7</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IND/IDE Number</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae1.5">mae1.5</a> = Yes (expandedYes-NoIndicator#Y)</span><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Organization/Site</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae4.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae4.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Where Adverse Medical Event Occurred</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.1.7" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae4.1.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the Adverse Medical Event occur at the lead principal investigator site?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae4.1.7">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.1.7_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.1.7_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select &quot;Yes&quot; if the Adverse Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" id="item.ExternalDataFor_mae4.1.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> ExternalDataFor_mae4.1.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">External Data For linkId mae4.1.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-open-choice">open-choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.1.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae4.1.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae4.1.7">mae4.1.7</a> = No (expandedYes-NoIndicator#N)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.1.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae4.1.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" id="item.mae4.1.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae4.1.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of organization/site where the event occurred</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae4.1.7">mae4.1.7</a> exists true</span><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae4.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae4.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Location where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae4.7" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae4.7</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site Principal Investigator</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae4.1.7">mae4.1.7</a> exists true</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.7.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.7.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First or given name of the principal investigator at site where Adverse Medical Event occurred</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.7.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Last Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.7.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Surname or family name</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.7.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Suffix</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.7.5_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.7.6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Degree(s)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.7.6_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7.6_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae4.7.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Phone</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae4.7.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">10-digit phone number, including area code</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" id="item.mae4.7.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae4.7.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Email</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae4.7_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4.7_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Principal Investigator at site where Adverse Medical Event occurred</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" id="item.mae4.9" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae4.9</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Responsibility for Adverse Medical Event Reporting</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae4.1.7">mae4.1.7</a> exists true</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1011.png)" id="item.mae4.9.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae4.9.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae4.1.7">mae4.1.7</a> = No (expandedYes-NoIndicator#N)</span><br/>Options: <a href="#opt-item.mae4.9.1">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10100.png)" id="item.mae4.9.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae4.9.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select &quot;Yes&quot; if the Adverse Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1001.png)" id="item.mae4.9.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae4.9.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of organization/site which is recording the Adverse Medical event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <ul><li><a href="#item.mae4.1.7">mae4.1.7</a> = Yes (expandedYes-NoIndicator#Y)</li><li><a href="#item.mae4.9.1">mae4.9.1</a> exists true</li></ul><br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">Calculated Value</a>: <code>iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10000.png)" id="item.mae4.9.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae4.9.2_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Location where adverse event is recorded</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Primary Contact</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae3_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Personnel completing the adverse medical event documentation at the lead or relying site</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae3.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae3.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First Name</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae3.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae3.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First or given name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae3.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae3.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Last Name</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae3.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae3.2_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Surname or family name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae3.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae3.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Phone</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae3.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae3.3_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">10-digit phone number, including area code</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" id="item.mae3.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae3.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Email</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant Information</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Patient ID</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant identifier from study case report form</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae5.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Age</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae5.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae5.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Birth Sex</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.3">4 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-quantity.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Quantity" class="hierarchy"/> mae5.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Weight</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-quantity">quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.4_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.4_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select pounds or kilograms</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-quantity.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Quantity" class="hierarchy"/> mae5.5</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Height</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-quantity">quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.5_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.5_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select inches, feet, centimeters, meters</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae5.6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ethnicity</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.6">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae5.7" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae5.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Race</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-choiceorientation.html" title="Orientation: vertical"><img src="icon-qi-vertical.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.7">5 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.8" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.8</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Which Arm/Cohort/treatment group was the participant assigned to (if known)?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.8_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.8_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Patient's treatment strategy assignment, if known.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.9" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.9</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant dosed or received study agent</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.9">4 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.9_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.9_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.10" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.10</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What study agent was received:</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <ul><li><a href="#item.mae5.9">mae5.9</a> = Yes (expandedYes-NoIndicator#Y)</li><li><a href="#item.mae5.9">mae5.9</a> = No Information (expandedYes-NoIndicator#NI)</li></ul><br/>Options: <a href="#opt-item.mae5.10">3 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.10_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.10_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">investigational agent or placebo or blinded study</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae5.11" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.11</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Were there any Protocol Deviations/Violations/Exceptions for this participant?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.11">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae5.11_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.11_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if adverse medical event occurred with protocol deviation, violation, exception</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" id="item.mae5.12" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae5.12</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe the Protocol Deviations/Violations/Exceptions</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae5.11">mae5.11</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1000.png)" id="item.mae5.12_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.12_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of protocol deviations, violations, or exceptions that occurred for this participant</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse Medical Event Information</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Submission Type</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.1">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial: the first time that the adverse medical event is reported
    or
    Update: update on a previously reported adverse medical event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date adverse event started</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reported Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date of this report</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Recorded Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.4_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date this adverse event was first recorded</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.10" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.10</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the Adverse Medical Event Serious?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.10">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.10_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.10_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Event is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.9" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.9</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Severity</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.9">3 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.9_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.9_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Physician assessment using sponsor defined categories</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.40" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.40</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Narrative of the Adverse Event:</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.40_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.40_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Medical Description of Adverse Event</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.5_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the Adverse Medical event still ongoing?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.6">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.6_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.6_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if the adverse event is still continuing or has been resolved.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.7" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.6">mae6.6</a> = No (expandedYes-NoIndicator#N)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.7_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.7_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date that the event resolved</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.8" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.8</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Was the event expected?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.8">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.8_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.8_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator that Adverse Medical Event was expected or not expected.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.11" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae6.11</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Seriousness</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae6.11.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.11.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Seriousness</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span><br/>Options: <a href="#opt-item.mae6.11.1">7 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae6.11.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.11.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">An adverse event is considered &quot;serious&quot; if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.32</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" id="item.mae6.11.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.11.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.11.1">mae6.11.1</a> = Other (Temporary Codes#Other)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" id="item.mae6.11.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.11.2_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe other serious consequences or other medically important condition</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.12" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Date" class="hierarchy"/> mae6.12</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What is the date Adverse Medical Event became serious?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.12_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.12_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date adverse event was deemed as serious</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.13" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.13</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Outcome of Adverse Medical Event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.13">6 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.13_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.13_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant's status after the adverse event</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.14" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.14</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Was autopsy performed?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.13">mae6.13</a> = Fatal (Temporary Codes#FATAL)</span><br/>Options: <a href="#opt-item.mae6.14">3 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.14_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.14_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if participant was autopsied</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae6.15" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.15</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Relationship of Adverse Medical Event to Study Intervention</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.15">6 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.16" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.16</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Rationale for relationship with study intervention</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.16_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.16_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Explanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.17" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.17</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If applicable, what are possible alternate causes of the Adverse Medical Event?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.17">6 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.17_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.17_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reason for possible alternative serious adverse event causes</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.18" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.18</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Procedure-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.17">mae6.17</a> = Study Procedure (Temporary Codes#STDYPRO)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.18_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.18_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study procedure associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.19" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.19</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pre-existing condition-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.17">mae6.17</a> = Pre-existing condition (Temporary Codes#PRE)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.19_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.19_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pre-existing condition associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.20" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.20</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Underlying disease-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.17">mae6.17</a> = Underlying disease (Temporary Codes#UNDERLYINGDIS)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.20_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.20_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Underlying disease associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.21" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.21</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomittant medication-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.17">mae6.17</a> = Concomitant medication (Temporary Codes#CONCMITMED)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.21_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.21_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomitant medication associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.22" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.22</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other known or suspected cause-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.17">mae6.17</a> = Other known or suspected cause (Temporary Codes#OTHERCAUSE)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.22_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.22_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of other causal reason associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.23" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae6.23</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Action Taken</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" id="item.mae6.23.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.23.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Action Taken Regarding Study Intervention</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.23.1">7 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" id="item.mae6.23.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.23.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Changes to study intervention made after adverse event was detected</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.24" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.24</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.24">3 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.24_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.24_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.25" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.25</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If study intervention was restarted (rechallenge) did AE recur?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.25">3 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" id="item.mae6.25_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.25_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event recurred when the study intervention was restarted</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" id="item.mae6.50" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6.50</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE Concomitant Medications, Treatments/Procedures and Tests</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" id="item.mae6.50.26" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.50.26</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the participant receive any relevant concomitant medications in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span><br/>Options: <a href="#opt-item.mae6.50.26">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae6.50.28" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6.50.28</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE Concomitant Medications</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.50.26">mae6.50.26</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.28.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.28.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Medication Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.28.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of concomitant medication given to participant in response to SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.28.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.28.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.28.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication for giving the concomitant medication to participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.28.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.50.28.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.28.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start date for the concomitant medication given to participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.28.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.50.28.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.28.4_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop date for the concomitant medication given to the participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.28.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.50.28.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ongoing</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.50.28.5">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.28.5_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is concomitant medication administration for participant ongoing?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae6.50.28_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.28_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomitant medication associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae6.50.29" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.50.29</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the participant receive any treatments/procedures in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span><br/>Options: <a href="#opt-item.mae6.50.29">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae6.50.29_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.29_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatments/procedures administered in response to SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae6.50.30" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6.50.30</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE Treatments/Procedures</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.50.29">mae6.50.29</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.30.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.30.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatment/Procedure</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.30.1_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.30.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.30.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.50.30.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.30.2_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.30.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start date for SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.30.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.50.30.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.30.3_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.30.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop date for SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11111.png)" id="item.mae6.50.30.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.50.30.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ongoing</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.50.30.4">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111100.png)" id="item.mae6.50.30.4_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.30.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the SAE treatment/procedure for the participant ongoing</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae6.50.30_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.30_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.png)" id="item.mae6.50.37" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.50.37</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.10">mae6.10</a> = Serious (AdverseEventSeriousness#serious)</span><br/>Options: <a href="#opt-item.mae6.50.37">2 options</a></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.png)" id="item.mae6.50.37_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.37_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Were any laboratory or diagnostic tests administered to the participant in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.png)" id="item.mae6.50.38" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6.50.38</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE Laboratory or Diagnostic Tests</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <span><a href="#item.mae6.50.37">mae6.50.37</a> = Yes (expandedYes-NoIndicator#Y)</span></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.38.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Lab/Diagnostic Test</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Date" class="hierarchy"/> mae6.50.38.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.3" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.38.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Result</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.4" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae6.50.38.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Low Range</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.5" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.50.38.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">High Range</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11010.png)" id="item.mae6.50.38.6" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae6.50.38.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Comments</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.png)" id="item.mae6.50.38_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.50.38_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Laboratory or diagnostic tests obtained in response to SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" id="item.mae6_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">An event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" id="item.mae11" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae11</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Optional Attachments</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae11.1" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae11.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe the file that is being attached (optional)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" id="item.mae11.2" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-attachment.png" alt="." style="background-color: white; background-color: inherit" title="Attachment" class="hierarchy"/> mae11.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Attachment</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-attachment">attachment</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" id="item.mae11_help" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae11_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Attachments related to the Adverse Event Report can be included here.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck01.png)" id="item.ADMIN00" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> ADMIN00</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Administrative Use Only</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" id="item.ADMIN01" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> ADMIN01</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Link ID prefix</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = mae</td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" id="item.ADMIN02" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> ADMIN02</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = temporarily unavailable<br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" id="item.ADMIN03" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> ADMIN03</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ID of the Research Study FHIR Resource associated with the study Questionnaire Responses</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = temporarily unavailable<br/>Expressions: <ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">Initial Value</a>: <code>%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value</code></li></ul></td></tr>
    <tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" id="item.ADMIN04" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> ADMIN04</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID of the local considerations Questionnaire Response, if any</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png" alt="icon"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr><td colspan="6" class="hierarchy"><br/><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table><hr/><p><b>Option Sets</b></p><a name="opt-item.mae1.3"> </a><p><b>Answer options for mae1.3</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INT (&quot;Interventional&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OBS (&quot;Observational&quot;)</li></ul><a name="opt-item.mae1.4"> </a><p><b>Answer options for mae1.4</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae1.5"> </a><p><b>Answer options for mae1.5</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae1.6"> </a><p><b>Answer options for mae1.6</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IND (&quot;IND&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IDE (&quot;IDE&quot;)</li></ul><a name="opt-item.mae4.1.7"> </a><p><b>Answer options for mae4.1.7</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae4.9.1"> </a><p><b>Answer options for mae4.9.1</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae5.3"> </a><p><b>Answer options for mae5.3</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0001#F (&quot;Female&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0001#M (&quot;Male&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0001#O (&quot;Other&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0001#U (&quot;Unknown&quot;)</li></ul><a name="opt-item.mae5.6"> </a><p><b>Answer options for mae5.6</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Ethnicity#2135-2 (&quot;Hispanic or Latino&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Ethnicity#2186-5 (&quot;Not Hispanic or Latino&quot;)</li></ul><a name="opt-item.mae5.7"> </a><p><b>Answer options for mae5.7</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Race#2028-9 (&quot;Asian&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Race#1002-5 (&quot;American Indian or Alaska Native&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Race#2054-5 (&quot;Black or African American&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Race#2076-8 (&quot;Native Hawaiian or Other Pacific Islander&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v3-Race#2106-3 (&quot;White&quot;)</li></ul><a name="opt-item.mae5.9"> </a><p><b>Answer options for mae5.9</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#NI (&quot;No Information&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae5.10"> </a><p><b>Answer options for mae5.10</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SA (&quot;Study Agent&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PLACEBO (&quot;Placebo&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#BSA (&quot;Blinded Study Agent&quot;)</li></ul><a name="opt-item.mae5.11"> </a><p><b>Answer options for mae5.11</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.1"> </a><p><b>Answer options for mae6.1</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#INITIAL (&quot;Initial&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UPDATE (&quot;Update&quot;)</li></ul><a name="opt-item.mae6.10"> </a><p><b>Answer options for mae6.10</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness#serious (&quot;Serious&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness#non-serious (&quot;Non-serious&quot;)</li></ul><a name="opt-item.mae6.9"> </a><p><b>Answer options for mae6.9</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-severity#mild (&quot;Mild&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-severity#moderate (&quot;Moderate&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-severity#severe (&quot;Severe&quot;)</li></ul><a name="opt-item.mae6.6"> </a><p><b>Answer options for mae6.6</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.8"> </a><p><b>Answer options for mae6.8</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0239#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0239#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.11.1"> </a><p><b>Answer options for mae6.11.1</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInDeath (&quot;Results in death&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IsLifeThreatening (&quot;Is Life-threatening&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInHospitalization (&quot;Requires or prolongs inpatient hospitalization&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#IsBirthDefect (&quot;Is a congenital anomaly/birth defect&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#ResultsInDisability (&quot;Results in persistent or significant disability/incapacity&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RequiresPreventImpairment (&quot;Requires intervention to prevent permanent impairment&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#Other (&quot;Other&quot;)</li></ul><a name="opt-item.mae6.13"> </a><p><b>Answer options for mae6.13</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RCVRED (&quot;recovered/resolved&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#RCVRING (&quot;recovering/resolving&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NRCVRED (&quot;not recovered/not resolved/ongoing&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#SEQL (&quot;recovered/resolved with sequelae&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#FATAL (&quot;fatal&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNK (&quot;unknown&quot;)</li></ul><a name="opt-item.mae6.14"> </a><p><b>Answer options for mae6.14</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#UNK (&quot;Unknown&quot;)</li></ul><a name="opt-item.mae6.15"> </a><p><b>Answer options for mae6.15</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#certain (&quot;Certain&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#probably-likely (&quot;Probably/Likely&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#possible (&quot;Possible&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#unlikely (&quot;Unlikely&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#conditional-classified (&quot;Conditional/Classified&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess#unassessable-unclassifiable (&quot;Unassessable/Unclassifiable&quot;)</li></ul><a name="opt-item.mae6.17"> </a><p><b>Answer options for mae6.17</b></p><ul><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRMYDIS (&quot;Primary disease&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#STDYPRO (&quot;Study Procedure&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#PRE (&quot;Pre-existing condition&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNDERLYINGDIS (&quot;Underlying disease&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#CONCMITMED (&quot;Concomitant medication&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#OTHERCAUSE (&quot;Other known or suspected cause&quot;)</li></ul><a name="opt-item.mae6.23.1"> </a><p><b>Answer options for mae6.23.1</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0251#WP (&quot;Product withdrawn permanently&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0251#WT (&quot;Product withdrawn temporarily&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0251#DR (&quot;Product dose or frequency of use reduced&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0251#DI (&quot;Product dose or frequency of use increased&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NC (&quot;Product dose or frequency of use not changed&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#UNK (&quot;Unknown&quot;)</li><li style="font-size: 11px">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#NA (&quot;Not applicable&quot;)</li></ul><a name="opt-item.mae6.24"> </a><p><b>Answer options for mae6.24</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae6.25"> </a><p><b>Answer options for mae6.25</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae6.50.26"> </a><p><b>Answer options for mae6.50.26</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.50.28.5"> </a><p><b>Answer options for mae6.50.28.5</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.50.29"> </a><p><b>Answer options for mae6.50.29</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.50.30.4"> </a><p><b>Answer options for mae6.50.30.4</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.50.37"> </a><p><b>Answer options for mae6.50.37</b></p><ul><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#Y (&quot;Yes&quot;)</li><li style="font-size: 11px">http://terminology.hl7.org/CodeSystem/v2-0532#N (&quot;No&quot;)</li></ul></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-launchContext">
        <extension url="name">
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="sourceQuestionnaireResponse"/>
            <display
                     value="The content of the Questionnaire Response transferred to this Questionnaire during form launch"/>
          </valueCoding>
        </extension>
        <extension url="type">
          <valueCode value="QuestionnaireResponse"/>
        </extension>
        <extension url="description">
          <valueString
                       value="The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire"/>
        </extension>
      </extension>
      <extension url="http://hl7.org/fhir/StructureDefinition/variable">
        <valueExpression>
          <description
                       value="variable to store the incoming data from the launchContext extension for populate and other expressions"/>
          <name value="lookupInitiateStudy"/>
          <language value="text/fhirpath"/>
          <expression value="%sourceQuestionnaireResponse"/>
        </valueExpression>
      </extension>
      <extension url="http://hl7.org/fhir/StructureDefinition/variable">
        <valueExpression>
          <description
                       value="event happened at the lead PI site/coordinating center"/>
          <name value="eventOccurredAtLeadPISite"/>
          <language value="text/fhirpath"/>
          <expression
                      value="%resource.descendants().where(linkId = 'mae4.1.7').answer.valueCoding.code"/>
        </valueExpression>
      </extension>
      <extension url="http://hl7.org/fhir/StructureDefinition/variable">
        <valueExpression>
          <description value="relying site where AE occurred"/>
          <name value="relyingSiteForForm"/>
          <language value="text/fhirpath"/>
          <expression
                      value="%resource.descendants().where(linkId = 'mae4.1.1').answer.value.display"/>
        </valueExpression>
      </extension>
      <extension url="http://hl7.org/fhir/StructureDefinition/variable">
        <valueExpression>
          <description value="being reported by lead PI site"/>
          <name value="relyingSiteEventReportedByLeadPISite"/>
          <language value="text/fhirpath"/>
          <expression
                      value="%resource.descendants().where(linkId = 'mae4.9.1').answer.valueCoding.code"/>
        </valueExpression>
      </extension>
      <url
           value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate"/>
      <version value="1.0.0"/>
      <name value="AE_Questionnaire"/>
      <title value="Adverse Medical Event Questionnaire"/>
      <status value="draft"/>
      <subjectType value="ResearchStudy"/>
      <date value="2023-04-24T20:03:27+00:00"/>
      <publisher value="HL7 International - BR&amp;R Work Group"/>
      <contact>
        <name value="HL7 International - Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
      </contact>
      <jurisdiction>
        <coding>
          <system value="urn:iso:std:iso:3166"/>
          <code value="US"/>
          <display value="United States of America"/>
        </coding>
        <text value="United States of America"/>
      </jurisdiction>
      <item>
        <linkId value="mae1"/>
        <text value="Research Study">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.1"/>
          <text value="Study Title"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae1.1_help"/>
            <text
                  value="Short title of the study, the same title listed on the Informed Consent"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.2"/>
          <text value="IRB Protocol Number"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae1.2_help"/>
            <text
                  value="Number assigned by IRB; this number is the same as that on the Consent Form"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in1.4').answer.valueCoding"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.3"/>
          <text value="Study Type"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="INT"/>
              <display value="Interventional"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="OBS"/>
              <display value="Observational"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae1.3_help"/>
            <text
                  value="Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in9.1').answer.valueCoding"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.4"/>
          <text value="Does this protocol require an FDA exemption?"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae1.4_help"/>
            <text value="Indicator for use of FDA regulated product"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in9.2').answer.valueCoding"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.5"/>
          <text value="Is an IND or IDE being used in this study?"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae1.5_help"/>
            <text
                  value="Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in9.4').answer.valueCoding"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.6"/>
          <text
                value="Select whether Investigational New Drug (IND) or Investigational Device Exemption (IDE):"/>
          <type value="choice"/>
          <enableWhen>
            <question value="mae1.5"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="IND"/>
              <display value="IND"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="IDE"/>
              <display value="IDE"/>
            </valueCoding>
          </answerOption>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'in9.3').answer.value"/>
            </valueExpression>
          </extension>
          <linkId value="mae1.7"/>
          <text value="IND/IDE Number"/>
          <type value="string"/>
          <enableWhen>
            <question value="mae1.5"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
        </item>
      </item>
      <item>
        <linkId value="mae4"/>
        <text value="Organization/Site">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <item>
          <linkId value="mae4.1"/>
          <text value="Where Adverse Medical Event Occurred">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <required value="false"/>
          <repeats value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae4.1.7"/>
            <text
                  value="Did the Adverse Medical Event occur at the lead principal investigator site?"/>
            <type value="choice"/>
            <required value="true"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
                <display value="Yes"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
                <display value="No"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.1.7_help"/>
              <text
                    value="This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. Select &quot;Yes&quot; if the Adverse Medical Event occurred at the lead principal investigator site, the study coordinating center or other administrative unit for the overall study."/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value"/>
              </valueExpression>
            </extension>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
              <valueBoolean value="true"/>
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/designNote">
              <valueMarkdown
                             value="See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic.  Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."/>
            </extension>
            <linkId value="ExternalDataFor_mae4.1.1"/>
            <text value="External Data For linkId mae4.1.1"/>
            <type value="open-choice"/>
            <required value="false"/>
            <repeats value="true"/>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-answerExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="%resource.repeat(item).where(linkId = 'ExternalDataFor_mae4.1.1').answer.value"/>
              </valueExpression>
            </extension>
            <extension url="http://hl7.org/fhir/StructureDefinition/designNote">
              <valueMarkdown
                             value="See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic.  Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression)."/>
            </extension>
            <linkId value="mae4.1.1"/>
            <text
                  value="If the Adverse Medical Event occurred at one of the relying sites, select the relying site in order to pre-populate the the relying institution and relying site principal investigator details below."/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae4.1.7"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.1.1_help"/>
              <text
                    value="This question and its answer will not print on the Adverse Medical Event Form but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details."/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.1.2"/>
            <text value="Name of organization/site where the event occurred"/>
            <type value="string"/>
            <enableWhen>
              <question value="mae4.1.7"/>
              <operator value="exists"/>
              <answerBoolean value="true"/>
            </enableWhen>
            <required value="false"/>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae4.1_help"/>
            <text
                  value="Location where Adverse Medical Event occurred. Adverse Medical Event is any untoward medical occurrence associated with a participant in research, whether or not associated with the participant's activities in the research."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae4.7"/>
          <text value="Site Principal Investigator">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <enableWhen>
            <question value="mae4.1.7"/>
            <operator value="exists"/>
            <answerBoolean value="true"/>
          </enableWhen>
          <required value="false"/>
          <repeats value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.1"/>
            <text value="First Name"/>
            <type value="string"/>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.7.1_help"/>
              <text
                    value="First or given name of the principal investigator at site where Adverse Medical Event occurred"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.2"/>
            <text value="Last Name"/>
            <type value="string"/>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.7.2_help"/>
              <text value="Surname or family name"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.5"/>
            <text value="Suffix"/>
            <type value="string"/>
            <required value="false"/>
            <repeats value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.7.5_help"/>
              <text
                    value="Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc."/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.6"/>
            <text value="Degree(s)"/>
            <type value="string"/>
            <required value="false"/>
            <repeats value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.7.6_help"/>
              <text
                    value="Professional and Academic degrees of the principal investigator at site where Adverse Medical Event occurred"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.5').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.5').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.3"/>
            <text value="Phone"/>
            <type value="string"/>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.7.3_help"/>
              <text value="10-digit phone number, including area code"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value, %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value)"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.7.4"/>
            <text value="Email"/>
            <type value="string"/>
            <required value="false"/>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae4.7_help"/>
            <text
                  value="Principal Investigator at site where Adverse Medical Event occurred"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae4.9"/>
          <text value="Responsibility for Adverse Medical Event Reporting">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <enableWhen>
            <question value="mae4.1.7"/>
            <operator value="exists"/>
            <answerBoolean value="true"/>
          </enableWhen>
          <required value="false"/>
          <repeats value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae4.9.1"/>
            <text
                  value="If the Adverse Medical Event occurred at a relying site, will the lead principal investigator site be recording the Adverse Non-Medical Event?"/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae4.1.7"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
              </answerCoding>
            </enableWhen>
            <required value="true"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
                <display value="Yes"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
                <display value="No"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.9.1_help"/>
              <text
                    value="Select &quot;Yes&quot; if the Adverse Medical Event is being recorded by the lead principal investigator site, the study coordinating center or other administrative unit for the overall study."/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-calculatedExpression">
              <valueExpression>
                <language value="text/fhirpath"/>
                <expression
                            value="iif(%eventOccurredAtLeadPISite = 'Y' or %relyingSiteEventReportedByLeadPISite = 'Y', %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value, iif(%relyingSiteEventReportedByLeadPISite = 'N', %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value) )"/>
              </valueExpression>
            </extension>
            <linkId value="mae4.9.2"/>
            <text
                  value="Name of organization/site which is recording the Adverse Medical event"/>
            <type value="string"/>
            <enableWhen>
              <question value="mae4.1.7"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
              </answerCoding>
            </enableWhen>
            <enableWhen>
              <question value="mae4.9.1"/>
              <operator value="exists"/>
              <answerBoolean value="true"/>
            </enableWhen>
            <enableBehavior value="any"/>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae4.9.2_help"/>
              <text value="Location where adverse event is recorded"/>
              <type value="display"/>
            </item>
          </item>
        </item>
      </item>
      <item>
        <linkId value="mae3"/>
        <text value="Primary Contact">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae3_help"/>
          <text
                value="Personnel completing the adverse medical event documentation at the lead or relying site"/>
          <type value="display"/>
        </item>
        <item>
          <linkId value="mae3.1"/>
          <text value="First Name"/>
          <type value="string"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae3.1_help"/>
            <text value="First or given name"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae3.2"/>
          <text value="Last Name"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae3.2_help"/>
            <text value="Surname or family name"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae3.3"/>
          <text value="Phone"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae3.3_help"/>
            <text value="10-digit phone number, including area code"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae3.4"/>
          <text value="Email"/>
          <type value="string"/>
          <required value="false"/>
        </item>
      </item>
      <item>
        <linkId value="mae5"/>
        <text value="Participant Information">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <item>
          <linkId value="mae5.1"/>
          <text value="Patient ID"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.1_help"/>
            <text value="Participant identifier from study case report form"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae5.2"/>
          <text value="Age"/>
          <type value="string"/>
          <required value="false"/>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae5.3"/>
          <text value="Birth Sex"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
              <code value="F"/>
              <display value="Female"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
              <code value="M"/>
              <display value="Male"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
              <code value="O"/>
              <display value="Other"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
              <code value="U"/>
              <display value="Unknown"/>
            </valueCoding>
          </answerOption>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[lb]"/>
            </valueCoding>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[kg]"/>
            </valueCoding>
          </extension>
          <linkId value="mae5.4"/>
          <text value="Weight"/>
          <type value="quantity"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.4_help"/>
            <text value="Select pounds or kilograms"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[in]"/>
            </valueCoding>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[ft]"/>
            </valueCoding>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[cm]"/>
            </valueCoding>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
            <valueCoding>
              <display value="[m]"/>
            </valueCoding>
          </extension>
          <linkId value="mae5.5"/>
          <text value="Height"/>
          <type value="quantity"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.5_help"/>
            <text value="Select inches, feet, centimeters, meters"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae5.6"/>
          <text value="Ethnicity"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
              <code value="2135-2"/>
              <display value="Hispanic or Latino"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
              <code value="2186-5"/>
              <display value="Not Hispanic or Latino"/>
            </valueCoding>
          </answerOption>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="check-box"/>
                <display value="Check-box"/>
              </coding>
              <text value="Check-box"/>
            </valueCodeableConcept>
          </extension>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation">
            <valueCode value="vertical"/>
          </extension>
          <linkId value="mae5.7"/>
          <text value="Race"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="true"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
              <code value="2028-9"/>
              <display value="Asian"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
              <code value="1002-5"/>
              <display value="American Indian or Alaska Native"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
              <code value="2054-5"/>
              <display value="Black or African American"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
              <code value="2076-8"/>
              <display value="Native Hawaiian or Other Pacific Islander"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
              <code value="2106-3"/>
              <display value="White"/>
            </valueCoding>
          </answerOption>
        </item>
        <item>
          <linkId value="mae5.8"/>
          <text
                value="Which Arm/Cohort/treatment group was the participant assigned to (if known)?"/>
          <type value="string"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.8_help"/>
            <text value="Patient's treatment strategy assignment, if known."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae5.9"/>
          <text value="Participant dosed or received study agent"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="NI"/>
              <display value="No Information"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="NA"/>
              <display value="not applicable"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.9_help"/>
            <text
                  value="Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae5.10"/>
          <text value="What study agent was received:"/>
          <type value="choice"/>
          <enableWhen>
            <question value="mae5.9"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
            </answerCoding>
          </enableWhen>
          <enableWhen>
            <question value="mae5.9"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="NI"/>
            </answerCoding>
          </enableWhen>
          <enableBehavior value="any"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="SA"/>
              <display value="Study Agent"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="PLACEBO"/>
              <display value="Placebo"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="BSA"/>
              <display value="Blinded Study Agent"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.10_help"/>
            <text value="investigational agent or placebo or blinded study"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae5.11"/>
          <text
                value="Were there any Protocol Deviations/Violations/Exceptions for this participant?"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.11_help"/>
            <text
                  value="Indicator if adverse medical event occurred with protocol deviation, violation, exception"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae5.12"/>
          <text value="Describe the Protocol Deviations/Violations/Exceptions"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae5.11"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="flyover"/>
                </coding>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae5.12_help"/>
            <text
                  value="Description of protocol deviations, violations, or exceptions that occurred for this participant"/>
            <type value="display"/>
          </item>
        </item>
      </item>
      <item>
        <linkId value="mae6"/>
        <text value="Adverse Medical Event Information">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.1"/>
          <text value="Submission Type"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="INITIAL"/>
              <display value="Initial"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="UPDATE"/>
              <display value="Update"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.1_help"/>
            <text
                  value="Initial: the first time that the adverse medical event is reported
    or
    Update: update on a previously reported adverse medical event"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.2"/>
          <text value="Start Date"/>
          <type value="date"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.2_help"/>
            <text value="Date adverse event started"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.3"/>
          <text value="Reported Date"/>
          <type value="date"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.3_help"/>
            <text value="Date of this report"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.4"/>
          <text value="Recorded Date"/>
          <type value="date"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.4_help"/>
            <text value="Date this adverse event was first recorded"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.10"/>
          <text value="Is the Adverse Medical Event Serious?"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="serious"/>
              <display value="Serious"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="non-serious"/>
              <display value="Non-serious"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.10_help"/>
            <text
                  value="Event is considered serious and reportable to the FDA in the following outcomes: death, life-threatening, hospitalization, disability or permanent damage, congenital anaomaly/birth defect, need for required intervention to prevent permanent impairment or damage. See FDA Guidance: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.9"/>
          <text value="Severity"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
              <code value="mild"/>
              <display value="Mild"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
              <code value="moderate"/>
              <display value="Moderate"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
              <code value="severe"/>
              <display value="Severe"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.9_help"/>
            <text value="Physician assessment using sponsor defined categories"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.40"/>
          <text value="Narrative of the Adverse Event:"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.10"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="serious"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.40_help"/>
            <text
                  value="Description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms. Serious Medical Event criteria are defined in the protocol."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.5"/>
          <text value="Medical Description of Adverse Event"/>
          <type value="text"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.5_help"/>
            <text
                  value="Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug or device, whether or not considered related to the drug or device."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.6"/>
          <text value="Is the Adverse Medical event still ongoing?"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.6_help"/>
            <text
                  value="Indicator if the adverse event is still continuing or has been resolved."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.7"/>
          <text value="Stop Date"/>
          <type value="date"/>
          <enableWhen>
            <question value="mae6.6"/>
            <operator value="="/>
            <answerCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.7_help"/>
            <text value="Date that the event resolved"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.8"/>
          <text value="Was the event expected?"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.8_help"/>
            <text
                  value="Indicator that Adverse Medical Event was expected or not expected."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.11"/>
          <text value="Seriousness">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <enableWhen>
            <question value="mae6.10"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="serious"/>
            </answerCoding>
          </enableWhen>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.11.1"/>
            <text value="Seriousness"/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae6.10"/>
              <operator value="="/>
              <answerCoding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
                <code value="serious"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="ResultsInDeath"/>
                <display value="Results in death"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="IsLifeThreatening"/>
                <display value="Is Life-threatening"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="ResultsInHospitalization"/>
                <display value="Requires or prolongs inpatient hospitalization"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="IsBirthDefect"/>
                <display value="Is a congenital anomaly/birth defect"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="ResultsInDisability"/>
                <display
                         value="Results in persistent or significant disability/incapacity"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="RequiresPreventImpairment"/>
                <display
                         value="Requires intervention to prevent permanent impairment"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="Other"/>
                <display value="Other"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.11.1_help"/>
              <text
                    value="An adverse event is considered &quot;serious&quot; if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. DFR Title 21, Part 312, Subpart B, Sec. 312.32"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <linkId value="mae6.11.2"/>
            <text value="Other-specify"/>
            <type value="text"/>
            <enableWhen>
              <question value="mae6.11.1"/>
              <operator value="="/>
              <answerCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="Other"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.11.2_help"/>
              <text
                    value="Describe other serious consequences or other medically important condition"/>
              <type value="display"/>
            </item>
          </item>
        </item>
        <item>
          <linkId value="mae6.12"/>
          <text value="What is the date Adverse Medical Event became serious?"/>
          <type value="date"/>
          <enableWhen>
            <question value="mae6.10"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="serious"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.12_help"/>
            <text value="Date adverse event was deemed as serious"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.13"/>
          <text value="Outcome of Adverse Medical Event"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="RCVRED"/>
              <display value="recovered/resolved"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="RCVRING"/>
              <display value="recovering/resolving"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="NRCVRED"/>
              <display value="not recovered/not resolved/ongoing"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="SEQL"/>
              <display value="recovered/resolved with sequelae"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="FATAL"/>
              <display value="fatal"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="UNK"/>
              <display value="unknown"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.13_help"/>
            <text value="Participant's status after the adverse event"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.14"/>
          <text value="Was autopsy performed?"/>
          <type value="choice"/>
          <enableWhen>
            <question value="mae6.13"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="FATAL"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="UNK"/>
              <display value="Unknown"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.14_help"/>
            <text value="Indicator if participant was autopsied"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.15"/>
          <text
                value="Relationship of Adverse Medical Event to Study Intervention"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="certain"/>
              <display value="Certain"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="probably-likely"/>
              <display value="Probably/Likely"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="possible"/>
              <display value="Possible"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="unlikely"/>
              <display value="Unlikely"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="conditional-classified"/>
              <display value="Conditional/Classified"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
              <code value="unassessable-unclassifiable"/>
              <display value="Unassessable/Unclassifiable"/>
            </valueCoding>
          </answerOption>
        </item>
        <item>
          <linkId value="mae6.16"/>
          <text value="Rationale for relationship with study intervention"/>
          <type value="text"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.16_help"/>
            <text
                  value="Explanation for relationship between study intervention and adverse event. You may also discuss why the AE appears to be unrelated or why it is not possible to determine the relationship."/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.17"/>
          <text
                value="If applicable, what are possible alternate causes of the Adverse Medical Event?"/>
          <type value="choice"/>
          <required value="false"/>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="PRMYDIS"/>
              <display value="Primary disease"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="STDYPRO"/>
              <display value="Study Procedure"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="PRE"/>
              <display value="Pre-existing condition"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="UNDERLYINGDIS"/>
              <display value="Underlying disease"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="CONCMITMED"/>
              <display value="Concomitant medication"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="OTHERCAUSE"/>
              <display value="Other known or suspected cause"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.17_help"/>
            <text
                  value="Reason for possible alternative serious adverse event causes"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.18"/>
          <text value="Study Procedure-specify"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.17"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="STDYPRO"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.18_help"/>
            <text value="Study procedure associated with SAE"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.19"/>
          <text value="Pre-existing condition-specify"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.17"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="PRE"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.19_help"/>
            <text value="Pre-existing condition associated with SAE"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.20"/>
          <text value="Underlying disease-specify"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.17"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="UNDERLYINGDIS"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.20_help"/>
            <text value="Underlying disease associated with SAE"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.21"/>
          <text value="Concomittant medication-specify"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.17"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="CONCMITMED"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.21_help"/>
            <text value="Concomitant medication associated with SAE"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.22"/>
          <text value="Other known or suspected cause-specify"/>
          <type value="text"/>
          <enableWhen>
            <question value="mae6.17"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
              <code value="OTHERCAUSE"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.22_help"/>
            <text value="Description of other causal reason associated with SAE"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.23"/>
          <text value="Action Taken">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.23.1"/>
            <text value="Action Taken Regarding Study Intervention"/>
            <type value="choice"/>
            <required value="false"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
                <code value="WP"/>
                <display value="Product withdrawn permanently"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
                <code value="WT"/>
                <display value="Product withdrawn temporarily"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
                <code value="DR"/>
                <display value="Product dose or frequency of use reduced"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
                <code value="DI"/>
                <display value="Product dose or frequency of use increased"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="NC"/>
                <display value="Product dose or frequency of use not changed"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="UNK"/>
                <display value="Unknown"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system
                        value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
                <code value="NA"/>
                <display value="Not applicable"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.23.1_help"/>
              <text
                    value="Changes to study intervention made after adverse event was detected"/>
              <type value="display"/>
            </item>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.24"/>
          <text
                value="If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="NA"/>
              <display value="not applicable"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.24_help"/>
            <text
                  value="Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="drop-down"/>
                <display value="Drop down"/>
              </coding>
              <text value="Drop down"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.25"/>
          <text
                value="If study intervention was restarted (rechallenge) did AE recur?"/>
          <type value="choice"/>
          <required value="false"/>
          <repeats value="false"/>
          <readOnly value="false"/>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="Y"/>
              <display value="Yes"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answerOption>
          <answerOption>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="NA"/>
              <display value="not applicable"/>
            </valueCoding>
          </answerOption>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="help"/>
                  <display value="Help-Button"/>
                </coding>
                <text value="Help-Button"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.25_help"/>
            <text
                  value="Adverse event recurred when the study intervention was restarted"/>
            <type value="display"/>
          </item>
        </item>
        <item>
          <linkId value="mae6.50"/>
          <text
                value="SAE Concomitant Medications, Treatments/Procedures and Tests">
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/rendering-style">
              <valueString value="color:#2a623d;  font-size: 125%"/>
            </extension>
          </text>
          <type value="group"/>
          <enableWhen>
            <question value="mae6.10"/>
            <operator value="="/>
            <answerCoding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
              <code value="serious"/>
            </answerCoding>
          </enableWhen>
          <required value="false"/>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.50.26"/>
            <text
                  value="Did the participant receive any relevant concomitant medications in response to the SAE?"/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae6.10"/>
              <operator value="="/>
              <answerCoding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
                <code value="serious"/>
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            </enableWhen>
            <required value="false"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
                <display value="Yes"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
                <display value="No"/>
              </valueCoding>
            </answerOption>
          </item>
          <item>
            <linkId value="mae6.50.28"/>
            <text value="SAE Concomitant Medications"/>
            <type value="group"/>
            <enableWhen>
              <question value="mae6.50.26"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <repeats value="true"/>
            <item>
              <linkId value="mae6.50.28.1"/>
              <text value="Medication Name"/>
              <type value="string"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.28.1_help"/>
                <text
                      value="Name of concomitant medication given to participant in response to SAE"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.28.2"/>
              <text value="Indication"/>
              <type value="string"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.28.2_help"/>
                <text
                      value="Indication for giving the concomitant medication to participant"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.28.3"/>
              <text value="Start Date"/>
              <type value="date"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.28.3_help"/>
                <text
                      value="Start date for the concomitant medication given to participant"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.28.4"/>
              <text value="Stop Date"/>
              <type value="date"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.28.4_help"/>
                <text
                      value="Stop date for the concomitant medication given to the participant"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="gtable"/>
                    <display value="Group Table"/>
                  </coding>
                  <text value="Group Table"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.28.5"/>
              <text value="Ongoing"/>
              <type value="choice"/>
              <required value="false"/>
              <answerOption>
                <valueCoding>
                  <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                  <code value="Y"/>
                  <display value="Yes"/>
                </valueCoding>
              </answerOption>
              <answerOption>
                <valueCoding>
                  <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                  <code value="N"/>
                  <display value="No"/>
                </valueCoding>
              </answerOption>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.28.5_help"/>
                <text
                      value="Is concomitant medication administration for participant ongoing?"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.28_help"/>
              <text value="Concomitant medication associated with SAE"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.50.29"/>
            <text
                  value="Did the participant receive any treatments/procedures in response to the SAE?"/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae6.10"/>
              <operator value="="/>
              <answerCoding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
                <code value="serious"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
                <display value="Yes"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
                <display value="No"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.29_help"/>
              <text
                    value="Treatments/procedures administered in response to SAE"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="gtable"/>
                  <display value="Group Table"/>
                </coding>
                <text value="Group Table"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.50.30"/>
            <text value="SAE Treatments/Procedures"/>
            <type value="group"/>
            <enableWhen>
              <question value="mae6.50.29"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <repeats value="true"/>
            <item>
              <linkId value="mae6.50.30.1"/>
              <text value="Treatment/Procedure"/>
              <type value="string"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.30.1_help"/>
                <text
                      value="Name of SAE treatment/procedure participant received"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.30.2"/>
              <text value="Start Date"/>
              <type value="date"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.30.2_help"/>
                <text
                      value="Start date for SAE treatment/procedure participant received"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.30.3"/>
              <text value="Stop Date"/>
              <type value="date"/>
              <required value="false"/>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.30.3_help"/>
                <text
                      value="Stop date for SAE treatment/procedure participant received"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <linkId value="mae6.50.30.4"/>
              <text value="Ongoing"/>
              <type value="choice"/>
              <required value="false"/>
              <answerOption>
                <valueCoding>
                  <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                  <code value="Y"/>
                  <display value="Yes"/>
                </valueCoding>
              </answerOption>
              <answerOption>
                <valueCoding>
                  <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                  <code value="N"/>
                  <display value="No"/>
                </valueCoding>
              </answerOption>
              <item>
                <extension
                           url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                  <valueCodeableConcept>
                    <coding>
                      <system
                              value="http://hl7.org/fhir/questionnaire-item-control"/>
                      <code value="help"/>
                      <display value="Help-Button"/>
                    </coding>
                    <text value="Help-Button"/>
                  </valueCodeableConcept>
                </extension>
                <linkId value="mae6.50.30.4_help"/>
                <text
                      value="Is the SAE treatment/procedure for the participant ongoing"/>
                <type value="display"/>
              </item>
            </item>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.30_help"/>
              <text value="SAE treatment/procedure participant received"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="drop-down"/>
                  <display value="Drop down"/>
                </coding>
                <text value="Drop down"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.50.37"/>
            <text
                  value="Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?"/>
            <type value="choice"/>
            <enableWhen>
              <question value="mae6.10"/>
              <operator value="="/>
              <answerCoding>
                <system
                        value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
                <code value="serious"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
                <display value="Yes"/>
              </valueCoding>
            </answerOption>
            <answerOption>
              <valueCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="N"/>
                <display value="No"/>
              </valueCoding>
            </answerOption>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.37_help"/>
              <text
                    value="Were any laboratory or diagnostic tests administered to the participant in response to the SAE?"/>
              <type value="display"/>
            </item>
          </item>
          <item>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
              <valueCodeableConcept>
                <coding>
                  <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                  <code value="gtable"/>
                  <display value="Group Table"/>
                </coding>
                <text value="Group Table"/>
              </valueCodeableConcept>
            </extension>
            <linkId value="mae6.50.38"/>
            <text value="SAE Laboratory or Diagnostic Tests"/>
            <type value="group"/>
            <enableWhen>
              <question value="mae6.50.37"/>
              <operator value="="/>
              <answerCoding>
                <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
                <code value="Y"/>
              </answerCoding>
            </enableWhen>
            <required value="false"/>
            <repeats value="true"/>
            <item>
              <linkId value="mae6.50.38.1"/>
              <text value="Lab/Diagnostic Test"/>
              <type value="string"/>
              <required value="false"/>
            </item>
            <item>
              <linkId value="mae6.50.38.2"/>
              <text value="Date"/>
              <type value="date"/>
              <required value="false"/>
            </item>
            <item>
              <linkId value="mae6.50.38.3"/>
              <text value="Result"/>
              <type value="string"/>
              <required value="false"/>
            </item>
            <item>
              <linkId value="mae6.50.38.4"/>
              <text value="Low Range"/>
              <type value="string"/>
              <required value="false"/>
            </item>
            <item>
              <linkId value="mae6.50.38.5"/>
              <text value="High Range"/>
              <type value="string"/>
              <required value="false"/>
            </item>
            <item>
              <linkId value="mae6.50.38.6"/>
              <text value="Comments"/>
              <type value="string"/>
              <required value="false"/>
            </item>
            <item>
              <extension
                         url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
                <valueCodeableConcept>
                  <coding>
                    <system
                            value="http://hl7.org/fhir/questionnaire-item-control"/>
                    <code value="help"/>
                    <display value="Help-Button"/>
                  </coding>
                  <text value="Help-Button"/>
                </valueCodeableConcept>
              </extension>
              <linkId value="mae6.50.38_help"/>
              <text
                    value="Laboratory or diagnostic tests obtained in response to SAE"/>
              <type value="display"/>
            </item>
          </item>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6_help"/>
          <text
                value="An event that (1) is more likely than not related to study activities; and (2) represents a new risk; and (3) is unanticipated. In addition, an expected event that is occurring at a frequency or intensity greater than originally anticipated."/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae11"/>
        <text value="Optional Attachments">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/rendering-style">
            <valueString value="color:#274e90; font-size: 150%"/>
          </extension>
        </text>
        <type value="group"/>
        <required value="false"/>
        <repeats value="true"/>
        <item>
          <linkId value="mae11.1"/>
          <text value="Describe the file that is being attached (optional)"/>
          <type value="string"/>
        </item>
        <item>
          <linkId value="mae11.2"/>
          <text value="Attachment"/>
          <type value="attachment"/>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae11_help"/>
          <text
                value="Attachments related to the Adverse Event Report can be included here."/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
          <valueBoolean value="true"/>
        </extension>
        <linkId value="ADMIN00"/>
        <text value="Administrative Use Only"/>
        <type value="group"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
            <valueBoolean value="true"/>
          </extension>
          <linkId value="ADMIN01"/>
          <text value="Link ID prefix"/>
          <type value="string"/>
          <required value="false"/>
          <initial>
            <valueString value="mae"/>
          </initial>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value"/>
            </valueExpression>
          </extension>
          <linkId value="ADMIN02"/>
          <text
                value="Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any"/>
          <type value="string"/>
          <required value="false"/>
          <initial>
            <valueString value="temporarily unavailable"/>
          </initial>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
            <valueBoolean value="true"/>
          </extension>
          <extension
                     url="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-initialExpression">
            <valueExpression>
              <language value="text/fhirpath"/>
              <expression
                          value="%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value"/>
            </valueExpression>
          </extension>
          <linkId value="ADMIN03"/>
          <text
                value="ID of the Research Study FHIR Resource associated with the study Questionnaire Responses"/>
          <type value="string"/>
          <required value="false"/>
          <initial>
            <valueString value="temporarily unavailable"/>
          </initial>
        </item>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
            <valueBoolean value="true"/>
          </extension>
          <linkId value="ADMIN04"/>
          <text
                value="Questionnaire Response ID of the local considerations Questionnaire Response, if any"/>
          <type value="string"/>
          <required value="false"/>
        </item>
      </item>
    </Questionnaire>