Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

## Extension: SeriousnessCriteria - XML Profile

Page standards status: Trial-use | Maturity Level: 2

XML representation of the seriousness-criteria extension.

Raw xml | Download

    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="seriousness-criteria"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension" title="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events.">Extension</a><a name="Extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Criteria reviewed in determining serious adverse event</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension">extension</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">2..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck15.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_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionCode" title="Slice criterionCode">extension:criterionCode</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Action criteria usually associated with events that pose a threat to a patient's life or functioning</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck150.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="text-decoration:line-through">extension</span><a name="Extension.extension.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck150.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionCode.url">url</a><a name="Extension.extension.url"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;criterionCode&quot;</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck140.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionCode.value[x]">value[x]</a><a name="Extension.extension.value_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Value of extension</span><br/><span style="font-weight:bold">Binding: </span><a href="http://terminology.hl7.org/5.5.0/ValueSet-adverse-event-clinical-research-seriousness-criteria.html" title="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria">Adverse Event Clinical Research Seriousness Criteria</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck15.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_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionPresent" title="Slice criterionPresent">extension:criterionPresent</a><a name="Extension.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Presence or absence of the specified criteria</td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck150.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <span style="text-decoration:line-through">extension</span><a name="Extension.extension.extension"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck150.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionPresent.url">url</a><a name="Extension.extension.url"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;criterionPresent&quot;</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck140.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_slice.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.extension:criterionPresent.value[x]">value[x]</a><a name="Extension.extension.value_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/datatypes.html#boolean">boolean</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Value of extension</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-seriousness-criteria-definitions.html#Extension.url">url</a><a name="Extension.url"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="color: darkgreen">&quot;http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria&quot;</span></td></tr>
    <tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck00.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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <span style="text-decoration:line-through">value[x]</span><a name="Extension.value_x_"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="text-decoration:line-through"/><span style="text-decoration:line-through">0</span><span style="text-decoration:line-through">..</span><span style="text-decoration:line-through">0</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
    <tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics">
        <valueCode value="can-bind"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="2">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/uv/ae-research-ig/ImplementationGuide/hl7.fhir.uv.ae-research-ig"/>
          </extension>
        </valueInteger>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
        <valueCode value="trial-use">
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
            <valueCanonical
                            value="http://hl7.org/fhir/uv/ae-research-ig/ImplementationGuide/hl7.fhir.uv.ae-research-ig"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"/>
      <version value="1.0.1"/>
      <name value="SeriousnessCriteria"/>
      <title value="Criteria reviewed in determining serious adverse event"/>
      <status value="active"/>
      <date value="2024-04-30T19:42:09+00:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="Biomedical Research and Regulation WG"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
      </contact>
      <description
                   value="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events."/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
        </coding>
      </jurisdiction>
      <fhirVersion value="5.0.0"/>
      <mapping>
        <identity value="rim"/>
        <uri value="http://hl7.org/v3"/>
        <name value="RIM Mapping"/>
      </mapping>
      <kind value="complex-type"/>
      <abstract value="false"/>
      <context>
        <type value="element"/>
        <expression value="AdverseEvent"/>
      </context>
      <type value="Extension"/>
      <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      <derivation value="constraint"/>
      <snapshot>
        <element id="Extension">
          <path value="Extension"/>
          <short value="Criteria reviewed in determining serious adverse event"/>
          <definition
                      value="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="Extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
        </element>
        <element id="Extension.id">
          <path value="Extension.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.extension">
          <path value="Extension.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Extension"/>
          <definition value="An Extension"/>
          <min value="2"/>
          <max value="*"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.extension:criterionCode">
          <path value="Extension.extension"/>
          <sliceName value="criterionCode"/>
          <short
                 value="Action criteria usually associated with events that pose a threat to a patient's life or functioning"/>
          <definition value="An Extension"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.extension:criterionCode.id">
          <path value="Extension.extension.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.extension:criterionCode.extension">
          <path value="Extension.extension.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Extension"/>
          <definition value="An Extension"/>
          <min value="0"/>
          <max value="0"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.extension:criterionCode.url">
          <path value="Extension.extension.url"/>
          <representation value="xmlAttr"/>
          <short value="identifies the meaning of the extension"/>
          <definition
                      value="Source of the definition for the extension code - a logical name or a URL."/>
          <comment
                   value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.url"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="uri"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <fixedUri value="criterionCode"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.extension:criterionCode.value[x]">
          <path value="Extension.extension.value[x]"/>
          <short value="Value of extension"/>
          <definition
                      value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.value[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <condition value="ext-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria"/>
          </binding>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.extension:criterionPresent">
          <path value="Extension.extension"/>
          <sliceName value="criterionPresent"/>
          <short value="Presence or absence of the specified criteria"/>
          <definition value="An Extension"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.extension:criterionPresent.id">
          <path value="Extension.extension.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="Extension.extension:criterionPresent.extension">
          <path value="Extension.extension.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Extension"/>
          <definition value="An Extension"/>
          <min value="0"/>
          <max value="0"/>
          <base>
            <path value="Element.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="Extension.extension:criterionPresent.url">
          <path value="Extension.extension.url"/>
          <representation value="xmlAttr"/>
          <short value="identifies the meaning of the extension"/>
          <definition
                      value="Source of the definition for the extension code - a logical name or a URL."/>
          <comment
                   value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.url"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="uri"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <fixedUri value="criterionPresent"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.extension:criterionPresent.value[x]">
          <path value="Extension.extension.value[x]"/>
          <short value="Value of extension"/>
          <definition
                      value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.value[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <condition value="ext-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.url">
          <path value="Extension.url"/>
          <representation value="xmlAttr"/>
          <short value="identifies the meaning of the extension"/>
          <definition
                      value="Source of the definition for the extension code - a logical name or a URL."/>
          <comment
                   value="The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Extension.url"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="uri"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <fixedUri
                    value="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="Extension.value[x]">
          <path value="Extension.value[x]"/>
          <short value="Value of extension"/>
          <definition
                      value="Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://hl7.org/fhir/R5/extensibility.html) for a list)."/>
          <min value="0"/>
          <max value="0"/>
          <base>
            <path value="Extension.value[x]"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="base64Binary"/>
          </type>
          <type>
            <code value="boolean"/>
          </type>
          <type>
            <code value="canonical"/>
          </type>
          <type>
            <code value="code"/>
          </type>
          <type>
            <code value="date"/>
          </type>
          <type>
            <code value="dateTime"/>
          </type>
          <type>
            <code value="decimal"/>
          </type>
          <type>
            <code value="id"/>
          </type>
          <type>
            <code value="instant"/>
          </type>
          <type>
            <code value="integer"/>
          </type>
          <type>
            <code value="integer64"/>
          </type>
          <type>
            <code value="markdown"/>
          </type>
          <type>
            <code value="oid"/>
          </type>
          <type>
            <code value="positiveInt"/>
          </type>
          <type>
            <code value="string"/>
          </type>
          <type>
            <code value="time"/>
          </type>
          <type>
            <code value="unsignedInt"/>
          </type>
          <type>
            <code value="uri"/>
          </type>
          <type>
            <code value="url"/>
          </type>
          <type>
            <code value="uuid"/>
          </type>
          <type>
            <code value="Address"/>
          </type>
          <type>
            <code value="Age"/>
          </type>
          <type>
            <code value="Annotation"/>
          </type>
          <type>
            <code value="Attachment"/>
          </type>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <type>
            <code value="CodeableReference"/>
          </type>
          <type>
            <code value="Coding"/>
          </type>
          <type>
            <code value="ContactPoint"/>
          </type>
          <type>
            <code value="Count"/>
          </type>
          <type>
            <code value="Distance"/>
          </type>
          <type>
            <code value="Duration"/>
          </type>
          <type>
            <code value="HumanName"/>
          </type>
          <type>
            <code value="Identifier"/>
          </type>
          <type>
            <code value="Money"/>
          </type>
          <type>
            <code value="Period"/>
          </type>
          <type>
            <code value="Quantity"/>
          </type>
          <type>
            <code value="Range"/>
          </type>
          <type>
            <code value="Ratio"/>
          </type>
          <type>
            <code value="RatioRange"/>
          </type>
          <type>
            <code value="Reference"/>
          </type>
          <type>
            <code value="SampledData"/>
          </type>
          <type>
            <code value="Signature"/>
          </type>
          <type>
            <code value="Timing"/>
          </type>
          <type>
            <code value="ContactDetail"/>
          </type>
          <type>
            <code value="DataRequirement"/>
          </type>
          <type>
            <code value="Expression"/>
          </type>
          <type>
            <code value="ParameterDefinition"/>
          </type>
          <type>
            <code value="RelatedArtifact"/>
          </type>
          <type>
            <code value="TriggerDefinition"/>
          </type>
          <type>
            <code value="UsageContext"/>
          </type>
          <type>
            <code value="Availability"/>
          </type>
          <type>
            <code value="ExtendedContactDetail"/>
          </type>
          <type>
            <code value="Dosage"/>
          </type>
          <type>
            <code value="Meta"/>
          </type>
          <condition value="ext-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
      </snapshot>
      <differential>
        <element id="Extension">
          <path value="Extension"/>
          <short value="Criteria reviewed in determining serious adverse event"/>
          <definition
                      value="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events."/>
        </element>
        <element id="Extension.extension">
          <path value="Extension.extension"/>
          <min value="2"/>
        </element>
        <element id="Extension.extension:criterionCode">
          <path value="Extension.extension"/>
          <sliceName value="criterionCode"/>
          <short
                 value="Action criteria usually associated with events that pose a threat to a patient's life or functioning"/>
          <min value="1"/>
          <max value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="Extension.extension:criterionCode.extension">
          <path value="Extension.extension.extension"/>
          <max value="0"/>
        </element>
        <element id="Extension.extension:criterionCode.url">
          <path value="Extension.extension.url"/>
          <fixedUri value="criterionCode"/>
        </element>
        <element id="Extension.extension:criterionCode.value[x]">
          <path value="Extension.extension.value[x]"/>
          <min value="1"/>
          <type>
            <code value="CodeableConcept"/>
          </type>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-seriousness-criteria"/>
          </binding>
        </element>
        <element id="Extension.extension:criterionPresent">
          <path value="Extension.extension"/>
          <sliceName value="criterionPresent"/>
          <short value="Presence or absence of the specified criteria"/>
          <min value="1"/>
          <max value="1"/>
        </element>
        <element id="Extension.extension:criterionPresent.extension">
          <path value="Extension.extension.extension"/>
          <max value="0"/>
        </element>
        <element id="Extension.extension:criterionPresent.url">
          <path value="Extension.extension.url"/>
          <fixedUri value="criterionPresent"/>
        </element>
        <element id="Extension.extension:criterionPresent.value[x]">
          <path value="Extension.extension.value[x]"/>
          <min value="1"/>
          <type>
            <code value="boolean"/>
          </type>
        </element>
        <element id="Extension.url">
          <path value="Extension.url"/>
          <fixedUri
                    value="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"/>
        </element>
        <element id="Extension.value[x]">
          <path value="Extension.value[x]"/>
          <max value="0"/>
        </element>
      </differential>
    </StructureDefinition>