Single Institutional Review Board (sIRB) Implementation Guide
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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

: Example Adverse Medical Event Questionnaire Response - XML Representation

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<QuestionnaireResponse xmlns="http://hl7.org/fhir">
  <id value="medical-ae-populate-exampleQR"/>
  <meta>
    <versionId value="1"/>
    <lastUpdated value="2022-03-12T01:53:26.773+00:00"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><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">Definition</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">Answer</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,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" 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="QuestionnaireResponseRoot" class="hierarchy"/> medical-ae-populate-exampleQR</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">QuestionnaireResponse</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></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)" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study of Drug A for arthritis</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_bck110.png)" 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="Item" class="hierarchy"/> mae1.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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">PRO098765</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="CodeSystem-temporarycodes.html#temporarycodes-INT">Temporary Codes</a> INT: Interventional</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae1.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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_bck100.png)" 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: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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_bck11.png)" 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"/> mae4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Organization/Site</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)" 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"/> mae4.1</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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)" 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="Item" class="hierarchy"/> mae4.1.7</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 Adverse Medical Event occur at the lead principal investigator site?</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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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)" 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="Item" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span>[not stated] : Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA</span></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)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> mae4.1.2</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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">Test Example University</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)" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Xi-Yang</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_bck1110.png)" 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="Item" class="hierarchy"/> mae4.7.2</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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Lee</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Jr.</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_bck1110.png)" 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="Item" class="hierarchy"/> mae4.7.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Degree(s)</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">MD, PhD</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">6781233456</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)" 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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> mae4.7.4</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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">XiYangLee@teu.med.edu</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_bck101.png)" 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"/><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_bck1010.png)" 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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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)" 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: white; background-color: inherit" title="Item" class="hierarchy"/> mae4.9.2</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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">Sample University Medical Center</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)" 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"/><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)" 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="Item" class="hierarchy"/> mae3.1</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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Jane</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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Doe</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)" 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="Item" class="hierarchy"/> mae3.3</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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">567-123-1234</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">drjanedoe@sampleuniversity.edu</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)" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">12345</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)" 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="Item" class="hierarchy"/> mae5.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Age</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">58</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_bck110.png)" 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="Item" class="hierarchy"/> mae5.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Birth Sex</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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0001.html#v2-0001-M">administrativeSex</a> M: Male</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae5.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Weight</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"><span><span>245 [lb]</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span>67 [in]</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae5.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ethnicity</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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-Ethnicity.html#v3-Ethnicity-2186-5">Ethnicity</a> 2186-5: Not Hispanic or Latino</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae5.7</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Race</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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-Race.html#v3-Race-2106-3">Race</a> 2106-3: White</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae5.8</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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">unknown</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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-NI">expandedYes-NoIndicator</a> NI: No Information</span></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_bck100.png)" 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: white; background-color: inherit" title="Item" class="hierarchy"/> mae5.11</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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_bck11.png)" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="CodeSystem-temporarycodes.html#temporarycodes-INITIAL">Temporary Codes</a> INITIAL: Initial</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae6.2</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</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">2021-11-05</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2021-11-06</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_bck110.png)" 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="Item" class="hierarchy"/> mae6.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Recorded Date</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">2021-11-06</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html#adverse-event-seriousness-serious">AdverseEventSeriousness</a> serious: Serious</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae6.9</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Severity</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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-severity.html#adverse-event-severity-mild">AdverseEventSeverity</a> mild: Mild</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Blood clot developed in right leg after several days of inactivity.  Participant experienced swelling and pain.</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_bck110.png)" 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="Item" class="hierarchy"/> mae6.5</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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">Deep Vein Thrombosis</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae6.7</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</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">2021-11-05</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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0239.html#v2-0239-N">eventExpected</a> N: No</span></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_bck111.png)" 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"/> mae6.11</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"/><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)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> mae6.11.1</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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="CodeSystem-temporarycodes.html#temporarycodes-ResultsInHospitalization">Temporary Codes</a> ResultsInHospitalization: Requires or prolongs inpatient hospitalization</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2021-11-05</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)" 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="Item" class="hierarchy"/> mae6.13</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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"><span><span><a href="CodeSystem-temporarycodes.html#temporarycodes-RCVRED">Temporary Codes</a> RCVRED: recovered/resolved</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-causality-assess.html#adverse-event-causality-assess-possible">AdverseEventCausalityAssessment</a> possible: Possible</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Patient was inactive for several days which might have been the cause.</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)" 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"/> mae6.23</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</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)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> mae6.23.1</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 Regarding 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0251.html#v2-0251-WT">actionTakenInResponseToTheEvent</a> WT: Product withdrawn temporarily</span></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_bck110.png)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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_bck110.png)" 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="Item" class="hierarchy"/> mae6.25</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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_bck101.png)" 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: #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"/><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_bck1010.png)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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)" 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-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"/><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_bck10110.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">warfarin</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_bck10110.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> mae6.50.28.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication</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">anticoagulant</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_bck10110.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2021-11-05</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_bck10110.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" class="hierarchy"/> mae6.50.28.4</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</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">2022-02-04</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)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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_bck1010.png)" 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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-N">expandedYes-NoIndicator</a> N: No</span></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_bck1010.png)" 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-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" class="hierarchy"/> mae6.50.37</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 relevant laboratory or diagnostic tests 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span><a href="http://terminology.hl7.org/5.0.0/CodeSystem-v2-0532.html#v2-0532-Y">expandedYes-NoIndicator</a> Y: Yes</span></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_bck1001.png)" 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-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"/><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_bck10010.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ultrasound</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_bck10010.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2021-11-05</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_bck10010.png)" 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.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">positive</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_bck10000.png)" 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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">blood clot noted</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)" 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"/><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)" 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="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatment instructions received from sponsor regarding this AE.</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_bck100.png)" 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: white; background-color: inherit" title="Item" 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"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span><span>No display for Attachment</span></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_bck01.png)" 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: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> ADMIN00</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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_bck010.png)" 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="Item" class="hierarchy"/> ADMIN01</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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">mae</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)" 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="Item" class="hierarchy"/> ADMIN02</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #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">initiate-study-populate-exampleQR</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)" 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="Item" class="hierarchy"/> ADMIN03</td><td style="vertical-align: top; text-align : left; background-color: white; 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: 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">ResearchStudyExample-sIRB</td></tr>
<tr><td colspan="4" class="hierarchy"><br/><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/workflow-researchStudy">
    <valueReference>
      <reference value="ResearchStudy/ResearchStudyExample-sIRB"/>
      <display value="ResearchStudyExample-sIRB"/>
    </valueReference>
  </extension>
  <questionnaire
                 value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire-populate"/>
  <status value="completed"/>
  <authored value="2022-03-12T01:53:25.336Z"/>
  <item>
    <linkId value="mae1"/>
    <text value="Research Study"/>
    <item>
      <linkId value="mae1.1"/>
      <text value="Study Title"/>
      <answer>
        <valueString value="Study of Drug A for arthritis"/>
      </answer>
    </item>
    <item>
      <linkId value="mae1.2"/>
      <text value="IRB Protocol Number"/>
      <answer>
        <valueString value="PRO098765"/>
      </answer>
    </item>
    <item>
      <linkId value="mae1.3"/>
      <text value="Study Type"/>
      <answer>
        <valueCoding>
          <system
                  value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="INT"/>
          <display value="Interventional"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae1.4"/>
      <text value="Does this protocol require an FDA exemption?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae1.5"/>
      <text value="Is an IND or IDE being used in this study?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answer>
    </item>
  </item>
  <item>
    <linkId value="mae4"/>
    <text value="Organization/Site"/>
    <item>
      <linkId value="mae4.1"/>
      <text value="Where Adverse Medical Event Occurred"/>
      <item>
        <linkId value="mae4.1.7"/>
        <text
              value="Did the Adverse Medical Event occur at the lead principal investigator site?"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="N"/>
            <display value="No"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="ExternalDataFor_mae4.1.1"/>
        <text value="External Data For linkId mae4.1.1"/>
        <answer>
          <valueString
                       value="Sample University Medical Center  |     |  Jane Doe, MD  |  Sample City, NC"/>
        </answer>
        <answer>
          <valueString
                       value="Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA"/>
        </answer>
        <answer>
          <valueString
                       value="Central Campus Test University  |     |  Maria Smith, PhD  |  Central, MI"/>
        </answer>
      </item>
      <item>
        <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."/>
        <answer>
          <valueCoding>
            <display
                     value="Test Example University  |     |  Xi-Yang Lee, Jr., MD, PhD  |  Example, MA"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="mae4.1.2"/>
        <text value="Name of organization/site where the event occurred"/>
        <answer>
          <valueString value="Test Example University"/>
        </answer>
      </item>
    </item>
    <item>
      <linkId value="mae4.7"/>
      <text value="Site Principal Investigator"/>
      <item>
        <linkId value="mae4.7.1"/>
        <text value="First Name"/>
        <answer>
          <valueString value="Xi-Yang"/>
        </answer>
      </item>
      <item>
        <linkId value="mae4.7.2"/>
        <text value="Last Name"/>
        <answer>
          <valueString value="Lee"/>
        </answer>
      </item>
      <item>
        <linkId value="mae4.7.5"/>
        <text value="Suffix"/>
        <answer>
          <valueString value="Jr."/>
        </answer>
      </item>
      <item>
        <linkId value="mae4.7.6"/>
        <text value="Degree(s)"/>
        <answer>
          <valueString value="MD, PhD"/>
        </answer>
      </item>
      <item>
        <linkId value="mae4.7.3"/>
        <text value="Phone"/>
        <answer>
          <valueString value="6781233456"/>
        </answer>
      </item>
      <item>
        <linkId value="mae4.7.4"/>
        <text value="Email"/>
        <answer>
          <valueString value="XiYangLee@teu.med.edu"/>
        </answer>
      </item>
    </item>
    <item>
      <linkId value="mae4.9"/>
      <text value="Responsibility for Adverse Medical Event Reporting"/>
      <item>
        <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?"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="Y"/>
            <display value="Yes"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="mae4.9.2"/>
        <text
              value="Name of organization/site which is recording the Adverse Medical event"/>
        <answer>
          <valueString value="Sample University Medical Center"/>
        </answer>
      </item>
    </item>
  </item>
  <item>
    <linkId value="mae3"/>
    <text value="Primary Contact"/>
    <item>
      <linkId value="mae3.1"/>
      <text value="First Name"/>
      <answer>
        <valueString value="Jane"/>
      </answer>
    </item>
    <item>
      <linkId value="mae3.2"/>
      <text value="Last Name"/>
      <answer>
        <valueString value="Doe"/>
      </answer>
    </item>
    <item>
      <linkId value="mae3.3"/>
      <text value="Phone"/>
      <answer>
        <valueString value="567-123-1234"/>
      </answer>
    </item>
    <item>
      <linkId value="mae3.4"/>
      <text value="Email"/>
      <answer>
        <valueString value="drjanedoe@sampleuniversity.edu"/>
      </answer>
    </item>
  </item>
  <item>
    <linkId value="mae5"/>
    <text value="Participant Information"/>
    <item>
      <linkId value="mae5.1"/>
      <text value="Patient ID"/>
      <answer>
        <valueString value="12345"/>
      </answer>
    </item>
    <item>
      <linkId value="mae5.2"/>
      <text value="Age"/>
      <answer>
        <valueString value="58"/>
      </answer>
    </item>
    <item>
      <linkId value="mae5.3"/>
      <text value="Birth Sex"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
          <code value="M"/>
          <display value="Male"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae5.4"/>
      <text value="Weight"/>
      <answer>
        <valueQuantity>
          <value value="245"/>
          <unit value="[lb]"/>
        </valueQuantity>
      </answer>
    </item>
    <item>
      <linkId value="mae5.5"/>
      <text value="Height"/>
      <answer>
        <valueQuantity>
          <value value="67"/>
          <unit value="[in]"/>
        </valueQuantity>
      </answer>
    </item>
    <item>
      <linkId value="mae5.6"/>
      <text value="Ethnicity"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
          <code value="2186-5"/>
          <display value="Not Hispanic or Latino"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae5.7"/>
      <text value="Race"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="2106-3"/>
          <display value="White"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae5.8"/>
      <text
            value="Which Arm/Cohort/treatment group was the participant assigned to (if known)?"/>
      <answer>
        <valueString value="unknown"/>
      </answer>
    </item>
    <item>
      <linkId value="mae5.9"/>
      <text value="Participant dosed or received study agent"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NI"/>
          <display value="No Information"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae5.11"/>
      <text
            value="Were there any Protocol Deviations/Violations/Exceptions for this participant?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answer>
    </item>
  </item>
  <item>
    <linkId value="mae6"/>
    <text value="Adverse Medical Event Information"/>
    <item>
      <linkId value="mae6.1"/>
      <text value="Submission Type"/>
      <answer>
        <valueCoding>
          <system
                  value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="INITIAL"/>
          <display value="Initial"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.2"/>
      <text value="Start Date"/>
      <answer>
        <valueDate value="2021-11-05"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.3"/>
      <text value="Reported Date"/>
      <answer>
        <valueDate value="2021-11-06"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.4"/>
      <text value="Recorded Date"/>
      <answer>
        <valueDate value="2021-11-06"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.10"/>
      <text value="Is the Adverse Medical Event Serious?"/>
      <answer>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
          <display value="Serious"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.9"/>
      <text value="Severity"/>
      <answer>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
          <code value="mild"/>
          <display value="Mild"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.40"/>
      <text value="Narrative of the Adverse Event:"/>
      <answer>
        <valueString
                     value="Blood clot developed in right leg after several days of inactivity.  Participant experienced swelling and pain."/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.5"/>
      <text value="Medical Description of Adverse Event"/>
      <answer>
        <valueString value="Deep Vein Thrombosis"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.6"/>
      <text value="Is the Adverse Medical event still ongoing?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.7"/>
      <text value="Stop Date"/>
      <answer>
        <valueDate value="2021-11-05"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.8"/>
      <text value="Was the event expected?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.11"/>
      <text value="Seriousness"/>
      <item>
        <linkId value="mae6.11.1"/>
        <text value="Seriousness"/>
        <answer>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="ResultsInHospitalization"/>
            <display value="Requires or prolongs inpatient hospitalization"/>
          </valueCoding>
        </answer>
      </item>
    </item>
    <item>
      <linkId value="mae6.12"/>
      <text value="What is the date Adverse Medical Event became serious?"/>
      <answer>
        <valueDate value="2021-11-05"/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.13"/>
      <text value="Outcome of Adverse Medical Event"/>
      <answer>
        <valueCoding>
          <system
                  value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="RCVRED"/>
          <display value="recovered/resolved"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.15"/>
      <text
            value="Relationship of Adverse Medical Event to Study Intervention"/>
      <answer>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"/>
          <code value="possible"/>
          <display value="Possible"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.16"/>
      <text value="Rationale for relationship with study intervention"/>
      <answer>
        <valueString
                     value="Patient was inactive for several days which might have been the cause."/>
      </answer>
    </item>
    <item>
      <linkId value="mae6.23"/>
      <text value="Action Taken"/>
      <item>
        <linkId value="mae6.23.1"/>
        <text value="Action Taken Regarding Study Intervention"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
            <code value="WT"/>
            <display value="Product withdrawn temporarily"/>
          </valueCoding>
        </answer>
      </item>
    </item>
    <item>
      <linkId value="mae6.24"/>
      <text
            value="If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did Adverse Medical Event diminish/abate?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.25"/>
      <text
            value="If study intervention was restarted (rechallenge) did AE recur?"/>
      <answer>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answer>
    </item>
    <item>
      <linkId value="mae6.50"/>
      <text
            value="SAE Concomitant Medications, Treatments/Procedures and Tests"/>
      <item>
        <linkId value="mae6.50.26"/>
        <text
              value="Did the participant receive any relevant concomitant medications in response to the SAE?"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="Y"/>
            <display value="Yes"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="mae6.50.28"/>
        <text value="SAE Concomitant Medications"/>
        <item>
          <linkId value="mae6.50.28.1"/>
          <text value="Medication Name"/>
          <answer>
            <valueString value="warfarin"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.28.2"/>
          <text value="Indication"/>
          <answer>
            <valueString value="anticoagulant"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.28.3"/>
          <text value="Start Date"/>
          <answer>
            <valueDate value="2021-11-05"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.28.4"/>
          <text value="Stop Date"/>
          <answer>
            <valueDate value="2022-02-04"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.28.5"/>
          <text value="Ongoing"/>
          <answer>
            <valueCoding>
              <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
              <code value="N"/>
              <display value="No"/>
            </valueCoding>
          </answer>
        </item>
      </item>
      <item>
        <linkId value="mae6.50.29"/>
        <text
              value="Did the participant receive any treatments/procedures in response to the SAE?"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="N"/>
            <display value="No"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="mae6.50.37"/>
        <text
              value="Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?"/>
        <answer>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="Y"/>
            <display value="Yes"/>
          </valueCoding>
        </answer>
      </item>
      <item>
        <linkId value="mae6.50.38"/>
        <text value="SAE Laboratory or Diagnostic Tests"/>
        <item>
          <linkId value="mae6.50.38.1"/>
          <text value="Lab/Diagnostic Test"/>
          <answer>
            <valueString value="ultrasound"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.38.2"/>
          <text value="Date"/>
          <answer>
            <valueDate value="2021-11-05"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.38.3"/>
          <text value="Result"/>
          <answer>
            <valueString value="positive"/>
          </answer>
        </item>
        <item>
          <linkId value="mae6.50.38.6"/>
          <text value="Comments"/>
          <answer>
            <valueString value="blood clot noted"/>
          </answer>
        </item>
      </item>
    </item>
  </item>
  <item>
    <linkId value="mae11"/>
    <text value="Optional Attachments"/>
    <item>
      <linkId value="mae11.1"/>
      <text value="Describe the file that is being attached (optional)"/>
      <answer>
        <valueString
                     value="Treatment instructions received from sponsor regarding this AE."/>
      </answer>
    </item>
    <item>
      <linkId value="mae11.2"/>
      <text value="Attachment"/>
      <answer>
        <valueAttachment>
          <url
               value="http://example.org/NationalGovernmentFunder/AE/NationalGovernmentFunderInstructions.pdf"/>
          <title value="NationalGovernmentFunderInstructions.pdf"/>
        </valueAttachment>
      </answer>
    </item>
  </item>
  <item>
    <linkId value="ADMIN00"/>
    <text value="Administrative Use Only"/>
    <item>
      <linkId value="ADMIN01"/>
      <text value="Link ID prefix"/>
      <answer>
        <valueString value="mae"/>
      </answer>
    </item>
    <item>
      <linkId value="ADMIN02"/>
      <text
            value="Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any"/>
      <answer>
        <valueString value="initiate-study-populate-exampleQR"/>
      </answer>
    </item>
    <item>
      <linkId value="ADMIN03"/>
      <text
            value="ID of the Research Study FHIR Resource associated with the study Questionnaire Responses"/>
      <answer>
        <valueString value="ResearchStudyExample-sIRB"/>
      </answer>
    </item>
  </item>
</QuestionnaireResponse>