HL7.FHIR.US.SIRB\Adverse Medical Event Questionnaire - XML Representation

This page is part of the Single Institutional Review Board (sIRB) Implementation Guide (v0.1.0: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions
: Adverse Medical Event Questionnaire - XML Representation

Raw xml | Download


<Questionnaire xmlns="http://hl7.org/fhir">
  <id value="sirb-adverse-event-questionnaire"/>
  <meta>
    <versionId value="30"/>
    <lastUpdated value="2021-07-25T19:43:52.262+00:00"/>
    <source value="#eJyAreQbrlvM9daT"/>
  </meta>
  <text>
    <status value="generated"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><b>Structure</b><table border="1" cellpadding="0" cellspacing="0" style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 2px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="The linkId for the item">LinkId</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Text for the item">Text</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Minimum and Maximum # of times the the itemcan appear in the instance">Cardinality</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="The type of the item">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Other attributes of the item">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Additional information about the item">Description &amp; Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_q_root.gif" alt="." style="background-color: white; background-color: inherit" title="QuestionnaireRoot" class="hierarchy"/> AE_Questionnaire</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae1.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Title</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Title from the Informed Consent</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae1.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IRB Protocol Number</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Number assigned to the protocol by IRB</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Type</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.3">2 options</a></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Does this protocol require an FDA exemption?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.4">2 options</a></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator for use of FDA regulated product</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae1.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is an IND or IDE being used in this study?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae1.5">2 options</a></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae1.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae1.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IND/IDE Number</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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"/> mae2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site Principal Investigator</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae2.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae2.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First or given name associated with the site principal investigator</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae2.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Last Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae2.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Surname or family name associated with the site principal investigator</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae2.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Suffix</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae2.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator's name</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae2.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Degree(s)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae2.6_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Professional and Academic degrees associated with the site investigator</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae2.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Phone</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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="String" class="hierarchy"/> mae2.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Email</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" 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"/> mae3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Primary Contact</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Personnel completing the adverse event documentation at the relying site</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> 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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae3.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Last Name</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" 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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae3.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Email</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> mae4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site/Organization</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Location where adverse event is recorded</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> 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">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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae4.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of organization/site which is recording the Adverse Medical event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Patient ID</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.1_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant identifier from study case report form</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Age</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae5.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Birth Sex</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.3">4 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-quantity.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Quantity" class="hierarchy"/> mae5.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Weight</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-quantity">quantity</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-quantity.png" alt="." style="background-color: white; background-color: inherit" title="Quantity" class="hierarchy"/> mae5.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Height</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-quantity">quantity</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ethnicity</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.6">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae5.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Race</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/uv/sdc/StructureDefinition/sdc-questionnaire-observationLinkPeriod" title="Orientation: vertical"><img src="icon-qi-vertical.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.7">5 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> mae5.8</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Which Arm/Cohort/treatment group was the participant assigned to (if known)?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.8_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Patient's treatment strategy assignment, if known.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.9</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant dosed or received study agent</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.9">4 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.9_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.10</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What study agent was received:</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae5.10">3 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.10_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">investigational agent or placebo or blinded study</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae5.11</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Were there any Protocol Deviations/Violations/Exceptions for this participant?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae5.11">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.11_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if adverse medical event occurred with protocol deviation, violation, exception</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae5.12</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe the Protocol Deviations/Violations/Exceptions</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae5.12_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of protocol deviations, violations, or exceptions that occurred for this participant</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> mae6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse Medical Event Information</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Submission Type</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.1">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Type of adverse event report being submitted</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date adverse event started</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reported Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date of this report</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Recorded Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date this adverse event was first recorded</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.5a</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Narrative of the Adverse Event:</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.5a_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Provide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms). Serious Medical Event criteria are defined in the protocol.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.5b</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Medical Description of Adverse Event</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.5b_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the Adverse Medical event still ongoing?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.6">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.6_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if adverse event is still continuing</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.7_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date that the event resolved</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.8</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Was the event expected?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.8">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.8_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event was expected or not</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.9</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Severity</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.9">3 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.9_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Physician assessment using sponsor defined categories</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.10</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the Adverse Medical Event Serious?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.10">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.10_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if an undesirable experience is associated with use of a medical product</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.11</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Seriousness</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae6.11">9 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.11_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Serious criteria are defined in the protocol</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> mae6.11b</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other-specify</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.11b_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe other serious consequences or other medically important condition</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.12</td><td style="vertical-align: top; text-align : left; background-color: white; 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: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.12_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date adverse event qualified as serious</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.13</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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.13">7 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.13_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant's status after the adverse event</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.14</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Was autopsy performed?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae6.14">3 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.14_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if participant was autopsied</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.15</td><td style="vertical-align: top; text-align : left; background-color: white; 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: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.15">5 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.16</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; 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: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.16_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Explanation for relationship between study intervention and adverse event</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.17</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What are possible alternate causes of the SAE?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae6.17">6 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: 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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.17_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reason for possible alternative serious adverse event causes</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.18</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Procedure-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.18_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study procedure associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.19</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pre-existing condition-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.19_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Pre-existing condition associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.20</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Underlying disease-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.20_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Underlying disease associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.21</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomittant medication-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.21_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomitant medication associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.22</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other known or suspected cause-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.22_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other causal reason was associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" 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 Regarding Study Intervention</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.23">6 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.23_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Changes to study intervention made after adverse event was detected</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> mae6.23b</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Other-specify</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-text">text</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.23b_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe other changes to intervention made after adverse event was detected</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.24</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.24">3 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.24_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck111.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.25</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If study intervention was restarted (rechallenge) did AE recur?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.25">3 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> mae6.25_help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Adverse event recurred when the study intervention was restarted</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> mae6.26</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 relevant concomitant medications in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae6.26">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> mae6.27</td><td style="vertical-align: top; text-align : left; background-color: white; 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: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.27_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Concomitant medication associated with SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.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="String" class="hierarchy"/> mae6.28.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Medication Name</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.28.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of concomitant medication given to participant in response to SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.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="String" class="hierarchy"/> mae6.28.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.28.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indication for giving the concomitant medication to participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.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-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.28.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.28.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start date for the concomitant medication given to participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1111.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-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.28.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11100.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_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.28.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop date for the concomitant medication given to the participant</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1101.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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.28.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ongoing</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.28.5">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11000.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_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.28.5_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is concomitant medication administration for participant ongoing?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.29</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 treatments/procedures in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-open-choice">open-choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae6.29">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.29_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatments/procedures administered in response to  SAE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" 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"/> mae6.30</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">SAE Treatments/Procedures</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.30_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae6.30.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Treatment/Procedure</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.30.1_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.30.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.30.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Start date for SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-date.png" alt="." style="background-color: white; background-color: inherit" title="Date" class="hierarchy"/> mae6.30.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop Date</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.30.3_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Stop date for SAE treatment/procedure participant received</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae6.30.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Ongoing</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-choice">choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Options: <a href="#opt-item.mae6.30.4">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae6.30.4_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is the SAE treatment/procedure for the participant ongoing</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> mae7</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">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-open-choice">open-choice</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: <br/>Options: <a href="#opt-item.mae7">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae7_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Were any laboratory or diagnostic tests administered to the participant in response to the SAE?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" 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"/> mae8</td><td style="vertical-align: top; text-align : left; background-color: white; 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: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Enable When: </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-display.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> mae8_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Laboratory or diagnostic tests obtained in response to AE</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> mae8.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Lab/Diagnostic Test</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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-date.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Date" class="hierarchy"/> mae8.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Date</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-date">date</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae8.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Result</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae8.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Low Range</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae8.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">High Range</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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="String" class="hierarchy"/> mae8.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Comments</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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: white; background-color: inherit" title="Group" class="hierarchy"/> ADMIN00</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Administrative Use Only</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> ADMIN01</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Link ID prefix</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = mae</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> ADMIN02</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = temporarily unavailable</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="String" class="hierarchy"/> ADMIN03</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ID of the Research Study FHIR Resource associated with the study Questionnaire Responses</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Initial Value: string = temporarily unavailable</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="String" class="hierarchy"/> ADMIN04</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID of the local considerations Questionnaire Response, if any</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/extension-questionnaire-hidden.html" title="Is a hidden item"><img src="icon-qi-hidden.png"/></a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr><td colspan="6" class="hierarchy"><br/><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table><hr/><p><b>Option Sets</b></p><a name="opt-item.mae1.3"> </a><p><b>Answer options for mae1.3</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: INT (&quot;Interventional&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: OBS (&quot;Observational&quot;)</li></ul><a name="opt-item.mae1.4"> </a><p><b>Answer options for mae1.4</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae1.5"> </a><p><b>Answer options for mae1.5</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae5.3"> </a><p><b>Answer options for mae5.3</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html">http://terminology.hl7.org/CodeSystem/v2-0001</a>: F (&quot;Female&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html">http://terminology.hl7.org/CodeSystem/v2-0001</a>: M (&quot;Male&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html">http://terminology.hl7.org/CodeSystem/v2-0001</a>: O (&quot;Other&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0001.html">http://terminology.hl7.org/CodeSystem/v2-0001</a>: U (&quot;Unknown&quot;)</li></ul><a name="opt-item.mae5.6"> </a><p><b>Answer options for mae5.6</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Ethnicity.html">http://terminology.hl7.org/CodeSystem/v3-Ethnicity</a>: 2135-2 (&quot;Hispanic or Latino&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Ethnicity.html">http://terminology.hl7.org/CodeSystem/v3-Ethnicity</a>: 2186-5 (&quot;Not Hispanic or Latino&quot;)</li></ul><a name="opt-item.mae5.7"> </a><p><b>Answer options for mae5.7</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2028-9 (&quot;Asian&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 1002-5 (&quot;American Indian or Alaska Native&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2054-5 (&quot;Black or African American&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2076-8 (&quot;Native Hawaiian or Other Pacific Islander&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v3-Race.html">http://terminology.hl7.org/CodeSystem/v3-Race</a>: 2106-3 (&quot;White&quot;)</li></ul><a name="opt-item.mae5.9"> </a><p><b>Answer options for mae5.9</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: NI (&quot;No Information&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae5.10"> </a><p><b>Answer options for mae5.10</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: SA (&quot;Study Agent&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PLACEBO (&quot;Placebo&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: BSA (&quot;Blinded Study Agent&quot;)</li></ul><a name="opt-item.mae5.11"> </a><p><b>Answer options for mae5.11</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.1"> </a><p><b>Answer options for mae6.1</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: INITIAL (&quot;Initial&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: UPDATE (&quot;Update&quot;)</li></ul><a name="opt-item.mae6.6"> </a><p><b>Answer options for mae6.6</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.8"> </a><p><b>Answer options for mae6.8</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0239.html">http://terminology.hl7.org/CodeSystem/v2-0239</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0239.html">http://terminology.hl7.org/CodeSystem/v2-0239</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.9"> </a><p><b>Answer options for mae6.9</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: mild (&quot;Mild&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: moderate (&quot;Moderate&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-severity.html">http://terminology.hl7.org/CodeSystem/adverse-event-severity</a>: severe (&quot;Severe&quot;)</li></ul><a name="opt-item.mae6.10"> </a><p><b>Answer options for mae6.10</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-seriousness.html">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness</a>: serious (&quot;Serious&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-adverse-event-seriousness.html">http://terminology.hl7.org/CodeSystem/adverse-event-seriousness</a>: non-serious (&quot;Non-serious&quot;)</li></ul><a name="opt-item.mae6.11"> </a><p><b>Answer options for mae6.11</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: D (&quot;Death&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: L (&quot;Life threatening&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: H (&quot;Caused hospitalized&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: P (&quot;Prolonged hospitalization&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: O (&quot;Other&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: C (&quot;Congenital anomaly/birth defect&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: I (&quot;Incapacity which is significant, persistent or permanent&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: J (&quot;Disability which is significant, persistent or permanent&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0240.html">http://terminology.hl7.org/CodeSystem/v2-0240</a>: R (&quot;Required intervention to prevent permanent impairment/damage&quot;)</li></ul><a name="opt-item.mae6.13"> </a><p><b>Answer options for mae6.13</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: F (&quot;Fully recovered&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: R (&quot;Recovering&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: N (&quot;Not recovering/unchanged&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: S (&quot;Sequelae&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: D (&quot;Died&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: W (&quot;Worsening&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0241.html">http://terminology.hl7.org/CodeSystem/v2-0241</a>: U (&quot;Unknown&quot;)</li></ul><a name="opt-item.mae6.14"> </a><p><b>Answer options for mae6.14</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: UNK (&quot;Unknown&quot;)</li></ul><a name="opt-item.mae6.15"> </a><p><b>Answer options for mae6.15</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html">http://terminology.hl7.org/CodeSystem/v2-0250</a>: N (&quot;Not related&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html">http://terminology.hl7.org/CodeSystem/v2-0250</a>: I (&quot;Improbable&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html">http://terminology.hl7.org/CodeSystem/v2-0250</a>: S (&quot;Somewhat probable&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html">http://terminology.hl7.org/CodeSystem/v2-0250</a>: M (&quot;Moderately probable&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0250.html">http://terminology.hl7.org/CodeSystem/v2-0250</a>: H (&quot;Highly probable&quot;)</li></ul><a name="opt-item.mae6.17"> </a><p><b>Answer options for mae6.17</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PRMYDIS (&quot;Primary disease&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: STDYPRO (&quot;Study Procedure&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PRE (&quot;Pre-existing condition&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: UNDERLYINGDIS (&quot;Underlying disease&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: CONCMITMED (&quot;Concomitant medication&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: OTHERCAUSE (&quot;Other known or suspected cause&quot;)</li></ul><a name="opt-item.mae6.23"> </a><p><b>Answer options for mae6.23</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: N (&quot;None&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: WP (&quot;Product withdrawn permanently&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: WT (&quot;Product withdrawn temporarily&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: DR (&quot;Product dose or frequency of use reduced&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: DI (&quot;Product dose or frequency of use increased&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0251.html">http://terminology.hl7.org/CodeSystem/v2-0251</a>: OT (&quot;Other&quot;)</li></ul><a name="opt-item.mae6.24"> </a><p><b>Answer options for mae6.24</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae6.25"> </a><p><b>Answer options for mae6.25</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: NA (&quot;not applicable&quot;)</li></ul><a name="opt-item.mae6.26"> </a><p><b>Answer options for mae6.26</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.28.5"> </a><p><b>Answer options for mae6.28.5</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.29"> </a><p><b>Answer options for mae6.29</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae6.30.4"> </a><p><b>Answer options for mae6.30.4</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul><a name="opt-item.mae7"> </a><p><b>Answer options for mae7</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: Y (&quot;Yes&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0532.html">http://terminology.hl7.org/CodeSystem/v2-0532</a>: N (&quot;No&quot;)</li></ul></div>
  </text>
  <extension url="http://hl7.org/fhir/StructureDefinition/variable">
    <valueExpression>
      <description value="response to get the data from"/>
      <name value="lookupInitiateStudy"/>
      <language value="application/x-fhir-query"/>
      <expression
                  value="https://docr-fhir.dev.cloud.duke.edu/hapi-fhir-jpaserver/fhir/QuestionnaireResponse/QRIDInitiateStudy"/>
    </valueExpression>
  </extension>
  <url
       value="http://hl7.org/fhir/us/sirb/Questionnaire/sirb-adverse-event-questionnaire"/>
  <version value="0.1.0"/>
  <name value="AE_Questionnaire"/>
  <title value="Adverse Medical Event Questionnaire"/>
  <status value="draft"/>
  <subjectType value="ResearchStudy"/>
  <date value="2021-08-10T13:15:03+00:00"/>
  <publisher value="HL7 International - BR&amp;R Work Group"/>
  <contact>
    <name value="HL7 International - Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
    <text value="United States of America"/>
  </jurisdiction>
  <item>
    <linkId value="mae1"/>
    <text value="RESEARCH STUDY"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="mae1.1"/>
      <text value="Study Title"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae1.1_help"/>
        <text value="Study Title from the Informed Consent"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae1.2"/>
      <text value="IRB Protocol Number"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae1.2_help"/>
        <text value="Number assigned to the protocol by IRB"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae1.3"/>
      <text value="Study Type"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="INT"/>
          <display value="Interventional"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="OBS"/>
          <display value="Observational"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae1.3_help"/>
        <text
              value="Select the study type, either Interventional (Clinical Trial) or Observational (Non-Interventional)"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae1.4"/>
      <text value="Does this protocol require an FDA exemption?"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae1.4_help"/>
        <text value="Indicator for use of FDA regulated product"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae1.5"/>
      <text value="Is an IND or IDE being used in this study?"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae1.5_help"/>
        <text
              value="Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) being used?"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae1.6"/>
      <text value="IND/IDE Number"/>
      <type value="string"/>
      <enableWhen>
        <question value="mae1.5"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
    </item>
  </item>
  <item>
    <linkId value="mae2"/>
    <text value="Site Principal Investigator"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="mae2.1"/>
      <text value="First Name"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae2.1_help"/>
        <text
              value="First or given name associated with the site principal investigator"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae2.2"/>
      <text value="Last Name"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae2.2_help"/>
        <text
              value="Surname or family name associated with the site principal investigator"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae2.5"/>
      <text value="Suffix"/>
      <type value="string"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae2.5_help"/>
        <text
              value="Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. associated with the site principal investigator&#39;s name"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae2.6"/>
      <text value="Degree(s)"/>
      <type value="string"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae2.6_help"/>
        <text
              value="Professional and Academic degrees associated with the site investigator"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae2.3"/>
      <text value="Phone"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae2.4"/>
      <text value="Email"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <linkId value="mae3"/>
    <text value="Primary Contact"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae3_help"/>
      <text
            value="Personnel completing the adverse event documentation at the relying site"/>
      <type value="display"/>
    </item>
    <item>
      <linkId value="mae3.1"/>
      <text value="First Name"/>
      <type value="string"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
    </item>
    <item>
      <linkId value="mae3.2"/>
      <text value="Last Name"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae3.3"/>
      <text value="Phone"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae3.4"/>
      <text value="Email"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <linkId value="mae4"/>
    <text value="Site/Organization"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae4_help"/>
      <text value="Location where adverse event is recorded"/>
      <type value="display"/>
    </item>
    <item>
      <linkId value="mae4.1"/>
      <text value="Name of organization/site where the event occurred"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae4.2"/>
      <text
            value="Name of organization/site which is recording the Adverse Medical event"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <linkId value="mae5"/>
    <text value="Participant Information"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="mae5.1"/>
      <text value="Patient ID"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.1_help"/>
        <text value="Participant identifier from study case report form"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae5.2"/>
      <text value="Age"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae5.3"/>
      <text value="Birth Sex"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
          <code value="F"/>
          <display value="Female"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
          <code value="M"/>
          <display value="Male"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
          <code value="O"/>
          <display value="Other"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0001"/>
          <code value="U"/>
          <display value="Unknown"/>
        </valueCoding>
      </answerOption>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[lb]"/>
        </valueCoding>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[kg]"/>
        </valueCoding>
      </extension>
      <linkId value="mae5.4"/>
      <text value="Weight"/>
      <type value="quantity"/>
      <required value="false"/>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[in]"/>
        </valueCoding>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[ft]"/>
        </valueCoding>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[cm]"/>
        </valueCoding>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-unitOption">
        <valueCoding>
          <display value="[m]"/>
        </valueCoding>
      </extension>
      <linkId value="mae5.5"/>
      <text value="Height"/>
      <type value="quantity"/>
      <required value="false"/>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae5.6"/>
      <text value="Ethnicity"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
          <code value="2135-2"/>
          <display value="Hispanic or Latino"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Ethnicity"/>
          <code value="2186-5"/>
          <display value="Not Hispanic or Latino"/>
        </valueCoding>
      </answerOption>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="check-box"/>
            <display value="Check-box"/>
          </coding>
          <text value="Check-box"/>
        </valueCodeableConcept>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-choiceOrientation">
        <valueCode value="vertical"/>
      </extension>
      <linkId value="mae5.7"/>
      <text value="Race"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="true"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="2028-9"/>
          <display value="Asian"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="1002-5"/>
          <display value="American Indian or Alaska Native"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="2054-5"/>
          <display value="Black or African American"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="2076-8"/>
          <display value="Native Hawaiian or Other Pacific Islander"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v3-Race"/>
          <code value="2106-3"/>
          <display value="White"/>
        </valueCoding>
      </answerOption>
    </item>
    <item>
      <linkId value="mae5.8"/>
      <text
            value="Which Arm/Cohort/treatment group was the participant assigned to (if known)?"/>
      <type value="string"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.8_help"/>
        <text value="Patient&#39;s treatment strategy assignment, if known."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae5.9"/>
      <text value="Participant dosed or received study agent"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NI"/>
          <display value="No Information"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NA"/>
          <display value="not applicable"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.9_help"/>
        <text
              value="Did the participant receive the investigational agent? If answer is unknown due to blinding, select No Information."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae5.10"/>
      <text value="What study agent was received:"/>
      <type value="choice"/>
      <enableWhen>
        <question value="mae5.9"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <enableWhen>
        <question value="mae5.9"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NI"/>
        </answerCoding>
      </enableWhen>
      <enableBehavior value="any"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="SA"/>
          <display value="Study Agent"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="PLACEBO"/>
          <display value="Placebo"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="BSA"/>
          <display value="Blinded Study Agent"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.10_help"/>
        <text value="investigational agent or placebo or blinded study"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae5.11"/>
      <text
            value="Were there any Protocol Deviations/Violations/Exceptions for this participant?"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.11_help"/>
        <text
              value="Indicator if adverse medical event occurred with protocol deviation, violation, exception"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae5.12"/>
      <text value="Describe the Protocol Deviations/Violations/Exceptions"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae5.11"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="flyover"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae5.12_help"/>
        <text
              value="Description of protocol deviations, violations, or exceptions that occurred for this participant"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="mae6"/>
    <text value="Adverse Medical Event Information"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.1"/>
      <text value="Submission Type"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="INITIAL"/>
          <display value="Initial"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="UPDATE"/>
          <display value="Update"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.1_help"/>
        <text value="Type of adverse event report being submitted"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.2"/>
      <text value="Start Date"/>
      <type value="date"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.2_help"/>
        <text value="Date adverse event started"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.3"/>
      <text value="Reported Date"/>
      <type value="date"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.3_help"/>
        <text value="Date of this report"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.4"/>
      <text value="Recorded Date"/>
      <type value="date"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.4_help"/>
        <text value="Date this adverse event was first recorded"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.5a"/>
      <text value="Narrative of the Adverse Event:"/>
      <type value="text"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.5a_help"/>
        <text
              value="Provide a discussion of the Adverse Event. If a Serious Medical Event, narrative must provide a description of the SAE including chronological clinical presentation and evolution of the SAE and associated signs/symptoms). Serious Medical Event criteria are defined in the protocol."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.5b"/>
      <text value="Medical Description of Adverse Event"/>
      <type value="text"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.5b_help"/>
        <text
              value="Diagnosis associated with adverse event. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.6"/>
      <text value="Is the Adverse Medical event still ongoing?"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.6_help"/>
        <text value="Indicator if adverse event is still continuing"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.7"/>
      <text value="Stop Date"/>
      <type value="date"/>
      <enableWhen>
        <question value="mae6.6"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.7_help"/>
        <text value="Date that the event resolved"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.8"/>
      <text value="Was the event expected?"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0239"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.8_help"/>
        <text value="Adverse event was expected or not"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.9"/>
      <text value="Severity"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
          <code value="mild"/>
          <display value="Mild"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
          <code value="moderate"/>
          <display value="Moderate"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
          <code value="severe"/>
          <display value="Severe"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.9_help"/>
        <text value="Physician assessment using sponsor defined categories"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.10"/>
      <text value="Is the Adverse Medical Event Serious?"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
          <display value="Serious"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="non-serious"/>
          <display value="Non-serious"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.10_help"/>
        <text
              value="Indicator if an undesirable experience is associated with use of a medical product"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.11"/>
      <text value="Seriousness"/>
      <type value="choice"/>
      <enableWhen>
        <question value="mae6.10"/>
        <operator value="="/>
        <answerCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="D"/>
          <display value="Death"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="L"/>
          <display value="Life threatening"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="H"/>
          <display value="Caused hospitalized"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="P"/>
          <display value="Prolonged hospitalization"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="O"/>
          <display value="Other"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="C"/>
          <display value="Congenital anomaly/birth defect"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="I"/>
          <display
                   value="Incapacity which is significant, persistent or permanent"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="J"/>
          <display
                   value="Disability which is significant, persistent or permanent"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="R"/>
          <display
                   value="Required intervention to prevent permanent impairment/damage"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.11_help"/>
        <text value="Serious criteria are defined in the protocol"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.11b"/>
      <text value="Other-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.11"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0240"/>
          <code value="O"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.11b_help"/>
        <text
              value="Describe other serious consequences or other medically important condition"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.12"/>
      <text value="What is the date Adverse Medical Event became serious?"/>
      <type value="date"/>
      <enableWhen>
        <question value="mae6.10"/>
        <operator value="="/>
        <answerCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.12_help"/>
        <text value="Date adverse event qualified as serious"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.13"/>
      <text value="Outcome of Adverse Medical Event"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="F"/>
          <display value="Fully recovered"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="R"/>
          <display value="Recovering"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="N"/>
          <display value="Not recovering/unchanged"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="S"/>
          <display value="Sequelae"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="D"/>
          <display value="Died"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="W"/>
          <display value="Worsening"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="U"/>
          <display value="Unknown"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.13_help"/>
        <text value="Participant&#39;s status after the adverse event"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.14"/>
      <text value="Was autopsy performed?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="mae6.13"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0241"/>
          <code value="D"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="UNK"/>
          <display value="Unknown"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.14_help"/>
        <text value="Indicator if participant was autopsied"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.15"/>
      <text value="Relationship of Adverse Medical Event to Study Intervention"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="N"/>
          <display value="Not related"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="I"/>
          <display value="Improbable"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="S"/>
          <display value="Somewhat probable"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="M"/>
          <display value="Moderately probable"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="H"/>
          <display value="Highly probable"/>
        </valueCoding>
      </answerOption>
    </item>
    <item>
      <linkId value="mae6.16"/>
      <text value="Rationale for relationship with study intervention"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.15"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="S"/>
        </answerCoding>
      </enableWhen>
      <enableWhen>
        <question value="mae6.15"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="M"/>
        </answerCoding>
      </enableWhen>
      <enableWhen>
        <question value="mae6.15"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="H"/>
        </answerCoding>
      </enableWhen>
      <enableBehavior value="any"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.16_help"/>
        <text
              value="Explanation for relationship between study intervention and adverse event"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.17"/>
      <text value="What are possible alternate causes of the SAE?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="mae6.15"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="N"/>
        </answerCoding>
      </enableWhen>
      <enableWhen>
        <question value="mae6.15"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0250"/>
          <code value="I"/>
        </answerCoding>
      </enableWhen>
      <enableBehavior value="any"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="PRMYDIS"/>
          <display value="Primary disease"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="STDYPRO"/>
          <display value="Study Procedure"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="PRE"/>
          <display value="Pre-existing condition"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="UNDERLYINGDIS"/>
          <display value="Underlying disease"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="CONCMITMED"/>
          <display value="Concomitant medication"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="OTHERCAUSE"/>
          <display value="Other known or suspected cause"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.17_help"/>
        <text
              value="Reason for possible alternative serious adverse event causes"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.18"/>
      <text value="Study Procedure-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.17"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="STDYPRO"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.18_help"/>
        <text value="Study procedure associated with SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.19"/>
      <text value="Pre-existing condition-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.17"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="PRE"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.19_help"/>
        <text value="Pre-existing condition associated with SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.20"/>
      <text value="Underlying disease-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.17"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="UNDERLYINGDIS"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.20_help"/>
        <text value="Underlying disease associated with SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.21"/>
      <text value="Concomittant medication-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.17"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="CONCMITMED"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.21_help"/>
        <text value="Concomitant medication associated with SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.22"/>
      <text value="Other known or suspected cause-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.17"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="OTHERCAUSE"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.22_help"/>
        <text value="Other causal reason was associated with SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.23"/>
      <text value="Action Taken Regarding Study Intervention"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="N"/>
          <display value="None"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="WP"/>
          <display value="Product withdrawn permanently"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="WT"/>
          <display value="Product withdrawn temporarily"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="DR"/>
          <display value="Product dose or frequency of use reduced"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="DI"/>
          <display value="Product dose or frequency of use increased"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="OT"/>
          <display value="Other"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.23_help"/>
        <text
              value="Changes to study intervention made after adverse event was detected"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.23b"/>
      <text value="Other-specify"/>
      <type value="text"/>
      <enableWhen>
        <question value="mae6.23"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0251"/>
          <code value="OT"/>
        </answerCoding>
      </enableWhen>
      <enableBehavior value="any"/>
      <required value="false"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.23b_help"/>
        <text
              value="Describe other changes to intervention made after adverse event was detected"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.24"/>
      <text
            value="If study intervention was discontinued, interrupted, or dose reduced (dechallenged), did AE diminish/abate?"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NA"/>
          <display value="not applicable"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.24_help"/>
        <text
              value="Adverse event diminished/abated after study intervention was discontinued, interrupted, or dose reduced (dechallenged)"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="mae6.25"/>
      <text
            value="If study intervention was restarted (rechallenge) did AE recur?"/>
      <type value="choice"/>
      <required value="false"/>
      <repeats value="false"/>
      <readOnly value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="NA"/>
          <display value="not applicable"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.25_help"/>
        <text
              value="Adverse event recurred when the study intervention was restarted"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.26"/>
      <text
            value="Did the participant receive any relevant concomitant medications in response to the SAE?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="mae6.10"/>
        <operator value="="/>
        <answerCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="gtable"/>
            <display value="Group Table"/>
          </coding>
          <text value="Group Table"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.27"/>
      <text value="SAE Concomitant Medications"/>
      <type value="group"/>
      <enableWhen>
        <question value="mae6.26"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.27_help"/>
        <text value="Concomitant medication associated with SAE"/>
        <type value="display"/>
      </item>
      <item>
        <linkId value="mae6.28.1"/>
        <text value="Medication Name"/>
        <type value="string"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.28.1_help"/>
          <text
                value="Name of concomitant medication given to participant in response to SAE"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.28.2"/>
        <text value="Indication"/>
        <type value="string"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.28.2_help"/>
          <text
                value="Indication for giving the concomitant medication to participant"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.28.3"/>
        <text value="Start Date"/>
        <type value="date"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.28.3_help"/>
          <text
                value="Start date for the concomitant medication given to participant"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.28.4"/>
        <text value="Stop Date"/>
        <type value="date"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.28.4_help"/>
          <text
                value="Stop date for the concomitant medication given to the participant"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.28.5"/>
        <text value="Ongoing"/>
        <type value="choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="Y"/>
            <display value="Yes"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="N"/>
            <display value="No"/>
          </valueCoding>
        </answerOption>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.28.5_help"/>
          <text
                value="Is concomitant medication administration for participant ongoing?"/>
          <type value="display"/>
        </item>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.29"/>
      <text
            value="Did the participant receive any treatments/procedures in response to the SAE?"/>
      <type value="open-choice"/>
      <enableWhen>
        <question value="mae6.10"/>
        <operator value="="/>
        <answerCoding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
          <display value="Yes"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.29_help"/>
        <text value="Treatments/procedures administered in response to  SAE"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="gtable"/>
            <display value="Group Table"/>
          </coding>
          <text value="Group Table"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae6.30"/>
      <text value="SAE Treatments/Procedures"/>
      <type value="group"/>
      <enableWhen>
        <question value="mae6.29"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="mae6.30_help"/>
        <text value="Name of SAE treatment/procedure participant received"/>
        <type value="display"/>
      </item>
      <item>
        <linkId value="mae6.30.1"/>
        <text value="Treatment/Procedure"/>
        <type value="string"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.30.1_help"/>
          <text value="Name of SAE treatment/procedure participant received"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.30.2"/>
        <text value="Start Date"/>
        <type value="date"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.30.2_help"/>
          <text
                value="Start date for SAE treatment/procedure participant received"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.30.3"/>
        <text value="Stop Date"/>
        <type value="date"/>
        <required value="false"/>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.30.3_help"/>
          <text
                value="Stop date for SAE treatment/procedure participant received"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="mae6.30.4"/>
        <text value="Ongoing"/>
        <type value="choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="Y"/>
            <display value="Yes"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
            <code value="N"/>
            <display value="No"/>
          </valueCoding>
        </answerOption>
        <item>
          <extension
                     url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
            <valueCodeableConcept>
              <coding>
                <system value="http://hl7.org/fhir/questionnaire-item-control"/>
                <code value="help"/>
                <display value="Help-Button"/>
              </coding>
              <text value="Help-Button"/>
            </valueCodeableConcept>
          </extension>
          <linkId value="mae6.30.4_help"/>
          <text
                value="Is the SAE treatment/procedure for the participant ongoing"/>
          <type value="display"/>
        </item>
      </item>
    </item>
  </item>
  <item>
    <extension
               url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
      <valueCodeableConcept>
        <coding>
          <system value="http://hl7.org/fhir/questionnaire-item-control"/>
          <code value="drop-down"/>
          <display value="Drop down"/>
        </coding>
        <text value="Drop down"/>
      </valueCodeableConcept>
    </extension>
    <linkId value="mae7"/>
    <text
          value="Did the participant receive relevant laboratory or diagnostic tests in response to the SAE?"/>
    <type value="open-choice"/>
    <enableWhen>
      <question value="mae6.10"/>
      <operator value="="/>
      <answerCoding>
        <system
                value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
        <code value="serious"/>
      </answerCoding>
    </enableWhen>
    <required value="false"/>
    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
        <code value="Y"/>
        <display value="Yes"/>
      </valueCoding>
    </answerOption>
    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
        <code value="N"/>
        <display value="No"/>
      </valueCoding>
    </answerOption>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae7_help"/>
      <text
            value="Were any laboratory or diagnostic tests administered to the participant in response to the SAE?"/>
      <type value="display"/>
    </item>
  </item>
  <item>
    <extension
               url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
      <valueCodeableConcept>
        <coding>
          <system value="http://hl7.org/fhir/questionnaire-item-control"/>
          <code value="gtable"/>
          <display value="Group Table"/>
        </coding>
        <text value="Group Table"/>
      </valueCodeableConcept>
    </extension>
    <linkId value="mae8"/>
    <text value="SAE Laboratory or Diagnostic Tests"/>
    <type value="group"/>
    <enableWhen>
      <question value="mae7"/>
      <operator value="="/>
      <answerCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
        <code value="Y"/>
      </answerCoding>
    </enableWhen>
    <required value="false"/>
    <repeats value="true"/>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="mae8_help"/>
      <text value="Laboratory or diagnostic tests obtained in response to AE"/>
      <type value="display"/>
    </item>
    <item>
      <linkId value="mae8.1"/>
      <text value="Lab/Diagnostic Test"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae8.2"/>
      <text value="Date"/>
      <type value="date"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae8.3"/>
      <text value="Result"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae8.4"/>
      <text value="Low Range"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae8.5"/>
      <text value="High Range"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="mae8.6"/>
      <text value="Comments"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <extension
               url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
      <valueBoolean value="true"/>
    </extension>
    <linkId value="ADMIN00"/>
    <text value="Administrative Use Only"/>
    <type value="group"/>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
        <valueBoolean value="true"/>
      </extension>
      <linkId value="ADMIN01"/>
      <text value="Link ID prefix"/>
      <type value="string"/>
      <required value="false"/>
      <initial>
        <valueString value="mae"/>
      </initial>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
        <valueBoolean value="true"/>
      </extension>
      <linkId value="ADMIN02"/>
      <text
            value="Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any"/>
      <type value="string"/>
      <required value="false"/>
      <initial>
        <valueString value="temporarily unavailable"/>
      </initial>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
        <valueBoolean value="true"/>
      </extension>
      <linkId value="ADMIN03"/>
      <text
            value="ID of the Research Study FHIR Resource associated with the study Questionnaire Responses"/>
      <type value="string"/>
      <required value="false"/>
      <initial>
        <valueString value="temporarily unavailable"/>
      </initial>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-hidden">
        <valueBoolean value="true"/>
      </extension>
      <linkId value="ADMIN04"/>
      <text
            value="Questionnaire Response ID of the local considerations Questionnaire Response, if any"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
</Questionnaire>