Single Institutional Review Board (sIRB) Implementation Guide
0.1.0 - STU 1 ballot

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

: Consent Questionnaire - XML Representation

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<Questionnaire xmlns="http://hl7.org/fhir">
  <id value="sirb-consent-questionnaire"/>
  <meta>
    <versionId value="34"/>
    <lastUpdated value="2021-07-28T23:23:05.246+00:00"/>
    <source value="#jpicEga4TSW9nuqD"/>
  </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"/> Consent_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"/> c1</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c1.1</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-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"/> c1.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Short Title of the 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-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"/> c1.2</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_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"/> c2</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"/> c2.2</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"/> c2.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">First or given name associated with the site primary responsibility holder</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"/> c2.1</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"/> c2.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Surname or family name associated with the site primary responsibility holder</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"/> c2.6</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"/> c2.6-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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"/> c2.3</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"/> c2.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Professional and Academic degrees associated with the site primary responsibility holder</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"/> c2.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Associated Institution</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"/> c2.4-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Academic or Profressional Institution associated with the site primary responsibility holder</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"/> c2.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Contact 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-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"/> c2.5-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Information on how to contact the Site PI.  Can include both email/phone number</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> c2-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution</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"/> c3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Relying Institution</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"/> c3.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name</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"/> c3.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Public or private entity conducting the study- where the participant will go or call</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"/> c3.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Address</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"/> c3.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Physical address</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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> c3-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Information about Lead or Site Institution where study will be conducted</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"/> c4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Sponsor or Funding Source</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> c4.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Sponsor 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_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: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> c4.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Entity financially supporting the research</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Sponsor Detail</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_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"/> c5-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Relevant information about the sponsor(s)</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"/> c6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is this consent an eConsent?</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.c6">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"/> c6-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Consent that is obtained electronically</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"/> c7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Summary Text</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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c7.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Summary Text Statement</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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"/></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"/> c7.1-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Mandated paragraph that describes the basic purpose, procedures and reasons behind the research in easily understood prose</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_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"/> c7-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Section header for the mandated text describing the basic purpose, procedures and reasons for the study.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c8</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Introduction and Statement of Research</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c8.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">About Consent Form</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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">Initial Value: string = This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision.  Please read this form carefully and ask questions about anything that is not clear before you agree to participate.  You may take this consent form home to think about and discuss with family or friends.</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> c8-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Introductory Paragraph to the participant.  Includes statement of research and explanation of the consent process:  This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision.  Please read this form carefully and ask questions about anything that is not clear before you agree to participate.  You may take this consent form home to think about and discuss with family or friends</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"/> c9</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Purpose</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c9.1</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 Research</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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"/> c9.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Explanation about why the study is being conducted</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"/> c9.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Interactions with others</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"/> c9.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Statement of who the participant can anticipate interacting with during their study participation</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"/> c9.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Invited Participants</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"/> c9.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">High level information about what participating in the study will entail for the participantr</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-integer.png" alt="." style="background-color: white; background-color: inherit" title="Integer" class="hierarchy"/> c9.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Total expected study enrollment</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-integer">integer</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"/> c9.4-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The number of people targeted for enrollment for the multi-site study</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c9.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional Enrollment Text</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"/> c9.5-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional field for including miscellaneous enrollment information. May include information about total enrollment from 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_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: white; background-color: inherit" title="Text" class="hierarchy"/> c9.6</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 involved in the 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-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_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: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> c9.6-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">High level information about what participating in the study will entail for 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_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"/> c10</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Assessments</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-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> c10.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Assessment List</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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"/> c10.1.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of the Assessment</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"/> c10.1.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Short name of the assessment</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c10.1.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of Assessment</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_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"/> c10.1.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Short description of the assessment</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c10.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Assessment Supplemental Text</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_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: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> c10.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional text if needed to provide additional context about the assessments collected</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"/> c11</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visits and 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..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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c11.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit Introductory Text</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"/></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"/> c11.1-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule.</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-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> c11.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit List</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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"/> c11.2.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit 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-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"/> c11.2.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Unique visit type, defined by the procedures which are completed within that visit.  E.g. Screening, Baseline, Followup, Final</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c11.2.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit Description</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_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"/> c11.2.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of Visit types, including what procedures it contains</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c11.2.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit Duration</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_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c11.2.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Visit Duration Units</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.c11.2.4">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-integer.png" alt="." style="background-color: white; background-color: inherit" title="Integer" class="hierarchy"/> c11.2.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Number of Visits</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-integer">integer</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-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> c11.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Procedure List</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: white; background-color: inherit" title="String" class="hierarchy"/> c11.3.1</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 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_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> c11.3.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Common Term of Procedure</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_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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c11.3.3</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 a 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-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_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c11.3.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Experimental Procedure Indicator</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.c11.3.4">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_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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> c11.3.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Research Indicator</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.c11.3.5">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_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-decimal.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Decimal" class="hierarchy"/> c11.3.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Frequency of Procedures</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..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-decimal">decimal</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-decimal.png" alt="." style="background-color: white; background-color: inherit" title="Decimal" class="hierarchy"/> c11.3.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Procedure Duration (minutes)</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-decimal">decimal</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"/> c11.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Procedure Supplemental Text</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"/></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"/> c11.4-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional Text to include after the procedure table to provide the participant any additional information needed about procedure schedule</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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> c11.5</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Total Duration of Study Participation</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_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"/> c11.5-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion</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"/> c12</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Risks</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-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> c12.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Risk List</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> c12.1.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name of the risk</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_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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c12.1.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of Risk</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c12.1.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Risk Category</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.c12.1.3">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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c12.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Risk Supplemental Text</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"/> c12.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional text for description of other costs not directly associated with a risk</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"/> c12.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Fetal Risks</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">Definition: 9.4<br/>Options: <a href="#opt-item.c12.3">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"/> c12.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates whether risks to the fetus are possible</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c12.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Fetal Risk Details</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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_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: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> c12.4-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Textual description of risks to the fetus</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"/> c13</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Alternative 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..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_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c13.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Alternative Procedure Text</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"/></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"/> c14</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Benefits</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_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"/> c14.1</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 Benefit</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c14.2</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 Benefit</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_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"/> c14.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Benefit to you</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.c14.3">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_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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> c14.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Benefit to society</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.c14.4">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_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"/> c15</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Compensation</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"/> c15.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will there be compensation for participation?</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">Definition: 12.1<br/>Options: <a href="#opt-item.c15.1">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"/> c15.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates whether compensation will be offered or not for the study</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c15.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Compensation Supplemental Text</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"/> c15.2_help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional text about compensation not captured in the compensation table</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"/> c15.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Compensation List</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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c15.3.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What types of visits or milestones will I be compensated for?</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"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-integer.png" alt="." style="background-color: white; background-color: inherit" title="Integer" class="hierarchy"/> c15.3.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">How many visits or milestones of this type will there be compensation for?</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-integer">integer</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_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c15.3.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">How much will be paid per that type of visit?</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"/></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"/> c16</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Costs</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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c16.1</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 the costs of participation, if any?</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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"/></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"/> c16.1-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Explanation informing  participant if any additional costs will occur to the participant as a result of taking part in the 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"/> c16.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will there be reimbursement for other study visit costs incurred?</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.c16.2">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"/> c16.2-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Reimbursement to participant for other study visit costs not directly associated with a visit</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"/> c16.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Who will pay for medical treatment if research related injury occurs?</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.c16.3">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"/> c16.3-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates if participant or the participant's insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury</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"/> c16.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Additional description of treatment coverage</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"/></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"/> c16.4-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of other costs not directly associated with a visit</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"/> c17</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participant Rights and whom to contact for answers</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c17.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">What are the rights of a 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-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"/> c17.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Statement of particpant rights</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"/> c17.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site IRB Contact 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-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"/> c17.2-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Contact information for the site IRB contact.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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"/> c17.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Study Coordinator Contact 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-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"/> c17.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Contact information for the site IRB contact.</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c17.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Site Principal Investigator Contact 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-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_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: #F7F7F7; background-color: inherit" title="Display" class="hierarchy"/> c17.4-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Contact information for the PI.  May be replicated from above.</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"/> c18</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Participation</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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c18.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Voluntary Permission Statement</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">Initial Value: string = Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.</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"/> c18.1-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Standard prepopulated statement, can be edited.</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"/> c18.2</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 the anticipated circumstances under which participant's participation may be terminated by the investigator without regard to the participant's or the legally authorized representative's 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-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"/></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"/> c18.2-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Anticipated circumstances under which subject's participation may be terminated by  investigator without regard to  subject's or  legally authorized representative's consent</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"/> c19</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Early Withdrawal</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_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"/> c19.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Are there consequences to participant for early withdrawal?</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">Definition: 18.1<br/>Options: <a href="#opt-item.c19.1">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_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"/> c19.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Are there Emotional Consequences of Withdrawal</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.c19.2">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"/> c19.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Are there Physical Consequences of Withdrawal</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.c19.3">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_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"/> c19.4</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 the consequences of withdrawal?</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"/> c19.4-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of the withdrawal consequences, will depend and vary based on type of 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_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"/> c20</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Confidentiality of Records</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_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"/> c20.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will HIPAA content be included within this document?</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">Definition: 19.2a<br/>Options: <a href="#opt-item.c20.1">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_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c20.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Medical information and billing statement</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: <br/>Initial Value: string = Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).  This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care.</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-coding.png" alt="." style="background-color: white; background-color: inherit" title="Coding" class="hierarchy"/> c20.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will confidentiality be protected?</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">Definition: 19.2<br/>Options: <a href="#opt-item.c20.3">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"/> c20.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates if records identifying a subject will be maintained.</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"/> c20.4</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">How will confidentiality be protected?</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"/> c20.4-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Explanation about processes and procedures to support maintaining privacy and confidentiality</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"/> c20.5</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Are there data security or policies that need to be included in the consent, particularly around device use (optional)</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">Definition: 19.3<br/>Options: <a href="#opt-item.c20.5">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"/> c20.5-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates if any data security policy applies to this consent, including device use.</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"/> c20.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Describe any data security policies and processes protecting the data</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"/> c20.6-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Optional field for capturing information on IT related data security policies.  Example, use of encryption when utilizing mobile data collection</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-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> c20.7</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Who can use or see 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..*</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_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c20.7.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Role or group who will have access to data</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-open-choice">open-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.c20.7.1">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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c20.7.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of Information Disclosed</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_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"/> c20.8</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will the data be released for future use?</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">Definition: 19.5<br/>Options: <a href="#opt-item.c20.8">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"/> c20.8-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates whether these data will be used beyond the study window</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"/> c20.9</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will the future use data be deidentified?</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">Definition: 19.5.1<br/>Enable When: <br/>Options: <a href="#opt-item.c20.9">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"/> c20.9-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicates if shared data will retain any identifiers.</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"/> c20.10</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Deidentification detail</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"/> c20.10-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of deidentification details for future use datasets. Two standardized statements, can be modified.</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c20.11</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Required text disclosure surrounding future use.</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.c20.11">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_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"/> c20.11-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Required Text disclosure surrounding future use of participant's data</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"/> c21</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Specimen Management</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-group">group</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_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"/> c21.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Were specimens collected as part of 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">Definition: 20.1<br/>Options: <a href="#opt-item.c21.1">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_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"/> c21.2</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is whole genome sequencing being conducted?</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.c21.2">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"/> c21.2-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator of if genome sequencing is being conducted in conjunction with 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"/> c21.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Sharing or no Sharing of samples.</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">Definition: 20.1.4<br/>Enable When: <br/>Options: <a href="#opt-item.c21.3">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"/> c21.3-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator of whether biospecimens will be shared outside of the immediate study team or institution.</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"/> c21.4</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Conditions of sharing</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"/> c21.4-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Textual description of sharing conditions including, type, when, etc.</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"/> c21.5</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will participant share in profit with commerical use?</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.c21.5">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"/> c21.5-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator of any plans to profit share any funds received as a result of commercial use of those samples.</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"/> c21.6</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of Collection and Storage</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"/> c21.6-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Textual description of collection and storage procedures and policies for the 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_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c21.7</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Can consent for sample use be revoked?</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.c21.7">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_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"/> c21.7-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 of revocation of sample consent is an option</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c22</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will there be Broad Consent for Storage, maintenance and secondary research use?</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">Definition: 21<br/>Options: <a href="#opt-item.c22">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_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: white; background-color: inherit" title="Display" class="hierarchy"/> c22.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If selected, participant identifiable information and identifiable biospecimens will be stored, used and shared for the kinds of future research described in this broad consent form, without anyone asking your permission for each new study.  Identifying information may also be removed from your information and biospecimens, allowing them to be used for any future research or other purpose.</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">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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c23</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Can the study team contact you for future research?</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">Definition: 22<br/>Options: <a href="#opt-item.c23">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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c23.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Conditions about contact for additional sample use, information not currently described or future research</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-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"/> c23.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Description of the details for which the participant could be contacted</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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> c23-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 the participant contact information can be used for future questions or recuitment for this or other studies</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c24</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will participants share in commercial profit?</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">Definition: 23<br/>Options: <a href="#opt-item.c24">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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c24.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Details about any profit sharing agreements or why profits will not be shared.</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_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"/> c24-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 of participants will receive any commercial profits resulting from their participation in study</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c25</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will the study team contact you with new information that may affect your willingness to remain in the 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.c25">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"/> c25-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  study team will provide updates that may affect  willingness to remain in study</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c26</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Will the study team disclose clinically relevant study results to you?</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">Definition: 25<br/>Options: <a href="#opt-item.c26">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_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"/> c26.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Condtions under which the study results will be disclosed to you</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"/> c26.1-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Textual description of which results and when will be disclosed to you.</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-display">display</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck100.png)" class="hierarchy"><img src="tbl_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"/> c26-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 of  study team will provide results of lab tests or other feedback of results to you at any time.</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_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c27</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Clinical Trials.gov statement</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"><a href="http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly" title="Is Readonly"><img src="icon-qi-readonly.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 = A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c28</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Is this study covered under a Certificate of Confidentiality? (default Y in NIH)</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">Definition: 26<br/>Options: <a href="#opt-item.c28">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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c28.1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Certificate of Confidentiality Statement</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"><a href="http://hl7.org/fhir/R4/questionnaire-definitions.html#Questionnaire.item.readOnly" title="Is Readonly"><img src="icon-qi-readonly.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">Enable When: <br/>Initial Value: string = The Department of Health and Human Services (HHS) has issued a Certificate of Confidentiality to further protect your privacy. With this Certificate, the investigators may not disclose research information that may identify you in any Federal, State, or local civil, criminal, administrative, legislative, or other proceedings, unless you have consented for this use.[trunc]</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"/> c28.1-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator if study is covered under a certificate of confidentiality (automatially issued for NIH studies)</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-text.png" alt="." style="background-color: white; background-color: inherit" title="Text" class="hierarchy"/> c28.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Required Disclosures based on state law</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_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-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c29</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">When will the PHI Authorization Expire based on date or time past an 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-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"/></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-display.png" alt="." style="background-color: white; background-color: inherit" title="Display" class="hierarchy"/> c29-help</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">PHI authorization expiration.  Might be never, a certain date, or a period after a study milestone, such as 6 months after study closure.</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_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-text.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Text" class="hierarchy"/> c30</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Statement of PHI Authorization Revocation</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">Initial Value: string = Participants have the ability to revoke their consent to share PHI at any time but that there are limitations on what restrictions can apply to data that has already been shared.</td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: white; background-color: inherit" title="Group" class="hierarchy"/> c31</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Signature</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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c31.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include Participant Signature and Date/Time</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.c31.1">2 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c31.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include Assent Signature and Date/Time</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.c31.2">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_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"/> c31.3</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include Legally Authorized Representative Signature and Date/Time</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.c31.3">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"/> c31.4</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 Legally Authorized Representative</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.c31.4">6 options</a></td></tr>
<tr style="border: 1px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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"/> c31.5</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include a Witness Signature and Date/Time</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.c31.5">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"/> c31.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include Parent 1 Signature and Date/Time</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.c31.6">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_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-coding.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Coding" class="hierarchy"/> c31.7</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Indicator to include Parent 2 Signature and Date/Time</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.c31.7">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_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"/> c32</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Protocol or Study 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-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-string.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> c32.1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">IRB Number</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/codesystem-item-type.html#item-type-string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></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"/> c32.2</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">sIRB Version Date of  Consent</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"/> c32.2-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 that changes whenever a change is made to the consent.  It is the versioning system of the sIRB institution, and is updated in accordance with the institution's policy.</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"/> c32.3</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Relying Site Version Date of Consent</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"/> c32.3-help</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A number that changes whenever a change is made to the consent.  It is the versioning system of the relying institution, and is updated in accordance with the institution's policy.</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-datetime.png" alt="." style="background-color: white; background-color: inherit" title="Date Time" class="hierarchy"/> c32.6</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Expiration Date of Consent</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-dateTime">dateTime</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_bck01.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon-q-group.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Group" class="hierarchy"/> ADMIN00</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Administrative Use Only</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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_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"/> ADMIN01</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Link ID prefix</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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 = c</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"/> ADMIN02</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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_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"/> ADMIN03</td><td style="vertical-align: top; text-align : left; background-color: white; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, 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_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: #F7F7F7; background-color: inherit" title="String" class="hierarchy"/> ADMIN04</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Questionnaire Response ID of the local considerations Questionnaire Response, if any</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 1px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">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"/></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.c6"> </a><p><b>Answer options for c6</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.c11.2.4"> </a><p><b>Answer options for c11.2.4</b></p><ul><li style="font-size: 11px"><a href="http://hl7.org/fhir/R4/ucum.html">UCUM</a>: min (&quot;min&quot;)</li><li style="font-size: 11px"><a href="http://hl7.org/fhir/R4/ucum.html">UCUM</a>: h (&quot;h&quot;)</li><li style="font-size: 11px"><a href="http://hl7.org/fhir/R4/ucum.html">UCUM</a>: d (&quot;d&quot;)</li></ul><a name="opt-item.c11.3.4"> </a><p><b>Answer options for c11.3.4</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.c11.3.5"> </a><p><b>Answer options for c11.3.5</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: RES (&quot;Research&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: STDCR (&quot;Standard of Care&quot;)</li></ul><a name="opt-item.c12.1.3"> </a><p><b>Answer options for c12.1.3</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: PHYS (&quot;Physical&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: NONPHYS (&quot;Non-Physical&quot;)</li></ul><a name="opt-item.c12.3"> </a><p><b>Answer options for c12.3</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.c14.3"> </a><p><b>Answer options for c14.3</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.c14.4"> </a><p><b>Answer options for c14.4</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.c15.1"> </a><p><b>Answer options for c15.1</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.c16.2"> </a><p><b>Answer options for c16.2</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.c16.3"> </a><p><b>Answer options for c16.3</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: TRTNOTCOV (&quot;Treatment not covered&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: RRICOV (&quot;Research Related injury covered&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: ACNOTCICOV (&quot;Acute but not chronic injury covered&quot;)</li></ul><a name="opt-item.c19.1"> </a><p><b>Answer options for c19.1</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.c19.2"> </a><p><b>Answer options for c19.2</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.c19.3"> </a><p><b>Answer options for c19.3</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.c20.1"> </a><p><b>Answer options for c20.1</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.c20.3"> </a><p><b>Answer options for c20.3</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.c20.5"> </a><p><b>Answer options for c20.5</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.c20.7.1"> </a><p><b>Answer options for c20.7.1</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: OTHINSTRES (&quot;Researchers at other institutions&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: THISINSTRES (&quot;Researchers outside the study team at this institution&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: EXTREGAUTH (&quot;External Regulatory Authorities&quot;)</li></ul><a name="opt-item.c20.8"> </a><p><b>Answer options for c20.8</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.c20.9"> </a><p><b>Answer options for c20.9</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></ul><a name="opt-item.c20.11"> </a><p><b>Answer options for c20.11</b></p><ul><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: DEIDUSED (&quot;Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent.&quot;)</li><li style="font-size: 11px"><a href="CodeSystem-temporarycodes.html">http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes</a>: DEIDNOTUSED (&quot;Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified.&quot;)</li></ul><a name="opt-item.c21.1"> </a><p><b>Answer options for c21.1</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.c21.2"> </a><p><b>Answer options for c21.2</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.c21.3"> </a><p><b>Answer options for c21.3</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.c21.5"> </a><p><b>Answer options for c21.5</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.c21.7"> </a><p><b>Answer options for c21.7</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.c22"> </a><p><b>Answer options for c22</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.c23"> </a><p><b>Answer options for c23</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.c24"> </a><p><b>Answer options for c24</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.c25"> </a><p><b>Answer options for c25</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.c26"> </a><p><b>Answer options for c26</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.c28"> </a><p><b>Answer options for c28</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.c31.1"> </a><p><b>Answer options for c31.1</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.c31.2"> </a><p><b>Answer options for c31.2</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.c31.3"> </a><p><b>Answer options for c31.3</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.c31.4"> </a><p><b>Answer options for c31.4</b></p><ul><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: PAR (&quot;Parent&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: SPO (&quot;Spouse&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: CHD (&quot;Child&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: SIB (&quot;Sibling&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: GRD (&quot;Guardian&quot;)</li><li style="font-size: 11px"><a href="https://terminology.hl7.org/1.0.0//CodeSystem-v2-0063.html">http://terminology.hl7.org/CodeSystem/v2-0063</a>: OTH (&quot;Other&quot;)</li></ul><a name="opt-item.c31.5"> </a><p><b>Answer options for c31.5</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.c31.6"> </a><p><b>Answer options for c31.6</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.c31.7"> </a><p><b>Answer options for c31.7</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-consent-questionnaire"/>
  <version value="0.1.0"/>
  <name value="Consent_Questionnaire"/>
  <title value="Consent 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="c1"/>
    <text value="Research Study"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c1.1"/>
      <text value="Study Title"/>
      <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="c1.1-help"/>
        <text value="Short Title of the Research Study"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c1.2"/>
      <text value="IRB Protocol Number"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <linkId value="c2"/>
    <text value="Site Principal Investigator"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c2.2"/>
      <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="c2.2-help"/>
        <text
              value="First or given name associated with the site primary responsibility holder"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c2.1"/>
      <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"/>
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        </extension>
        <linkId value="c2.1-help"/>
        <text
              value="Surname or family name associated with the site primary responsibility holder"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c2.6"/>
      <text value="Suffix"/>
      <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="c2.6-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="c2.3"/>
      <text value="Degree(s)"/>
      <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="c2.3-help"/>
        <text
              value="Professional and Academic degrees associated with the site primary responsibility holder"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c2.4"/>
      <text value="Associated Institution"/>
      <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="c2.4-help"/>
        <text
              value="Academic or Profressional Institution associated with the site primary responsibility holder"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c2.5"/>
      <text value="Contact Information"/>
      <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="c2.5-help"/>
        <text
              value="Information on how to contact the Site PI.  Can include both email/phone number"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c2-help"/>
      <text
            value="PI at a site conducting the study, responsible for the conduct of the study at his/her relying institution"/>
      <type value="display"/>
    </item>
  </item>
  <item>
    <linkId value="c3"/>
    <text value="Relying Institution"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c3.1"/>
      <text value="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="c3.1-help"/>
        <text
              value="Public or private entity conducting the study- where the participant will go or call"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c3.2"/>
      <text value="Address"/>
      <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="c3.2-help"/>
        <text value="Physical address"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c3-help"/>
      <text
            value="Information about Lead or Site Institution where study will be conducted"/>
      <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="c4"/>
    <text value="Sponsor or Funding Source"/>
    <type value="group"/>
    <required value="false"/>
    <repeats value="true"/>
    <item>
      <linkId value="c4.1"/>
      <text value="Sponsor 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="c4.1-help"/>
        <text value="Entity financially supporting the research"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c5"/>
    <text value="Sponsor Detail"/>
    <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="c5-help"/>
      <text value="Relevant information about the sponsor(s)"/>
      <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="c6"/>
    <text value="Is this consent an eConsent?"/>
    <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="c6-help"/>
      <text value="Consent that is obtained electronically"/>
      <type value="display"/>
    </item>
  </item>
  <item>
    <linkId value="c7"/>
    <text value="Summary Text"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c7.1"/>
      <text value="Summary Text Statement"/>
      <type value="text"/>
      <required 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="c7.1-help"/>
        <text
              value="Mandated paragraph that describes the basic purpose, procedures and reasons behind the research in easily understood prose"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c7-help"/>
      <text
            value="Section header for the mandated text describing the basic purpose, procedures and reasons for the study."/>
      <type value="display"/>
    </item>
  </item>
  <item>
    <linkId value="c8"/>
    <text value="Introduction and Statement of Research"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c8.1"/>
      <text value="About Consent Form"/>
      <type value="text"/>
      <required value="false"/>
      <initial>
        <valueString
                     value="This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision.  Please read this form carefully and ask questions about anything that is not clear before you agree to participate.  You may take this consent form home to think about and discuss with family or friends."/>
      </initial>
    </item>
    <item>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/questionnaire-itemControl">
        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
          </coding>
          <text value="Help-Button"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c8-help"/>
      <text
            value="Introductory Paragraph to the participant.  Includes statement of research and explanation of the consent process:  This consent form describes a research study, what you may expect if you decide to take part and important information to help you make your decision.  Please read this form carefully and ask questions about anything that is not clear before you agree to participate.  You may take this consent form home to think about and discuss with family or friends"/>
      <type value="display"/>
    </item>
  </item>
  <item>
    <linkId value="c9"/>
    <text value="Purpose"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c9.1"/>
      <text value="Reason for Research"/>
      <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="c9.1-help"/>
        <text value="Explanation about why the study is being conducted"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c9.2"/>
      <text value="Interactions with others"/>
      <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="c9.2-help"/>
        <text
              value="Statement of who the participant can anticipate interacting with during their study participation"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c9.3"/>
      <text value="Invited Participants"/>
      <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="c9.3-help"/>
        <text
              value="High level information about what participating in the study will entail for the participantr"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c9.4"/>
      <text value="Total expected study enrollment"/>
      <type value="integer"/>
      <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="c9.4-help"/>
        <text
              value="The number of people targeted for enrollment for the multi-site study"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c9.5"/>
      <text value="Additional Enrollment Text"/>
      <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="c9.5-help"/>
        <text
              value="Additional field for including miscellaneous enrollment information. May include information about total enrollment from the relying site"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c9.6"/>
      <text value="What is involved in the study?"/>
      <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="c9.6-help"/>
        <text
              value="High level information about what participating in the study will entail for the participant."/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c10"/>
    <text value="Assessments"/>
    <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="gtable"/>
            <display value="Group Table"/>
          </coding>
          <text value="Group Table"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c10.1"/>
      <text value="Assessment List"/>
      <type value="group"/>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <linkId value="c10.1.1"/>
        <text value="Name of the Assessment"/>
        <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="c10.1.1-help"/>
          <text value="Short name of the assessment"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="c10.1.2"/>
        <text value="Description of Assessment"/>
        <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="c10.1.2-help"/>
          <text value="Short description of the assessment"/>
          <type value="display"/>
        </item>
      </item>
    </item>
    <item>
      <linkId value="c10.2"/>
      <text value="Assessment Supplemental Text"/>
      <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="c10.2-help"/>
        <text
              value="Additional text if needed to provide additional context about the assessments collected"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c11"/>
    <text value="Visits and Procedures"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c11.1"/>
      <text value="Visit Introductory Text"/>
      <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="c11.1-help"/>
        <text
              value="Introductory Text to include prior to the visit table to introduce what the tables contain and explain any additional detail or information about the visit schedule."/>
        <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="c11.2"/>
      <text value="Visit List"/>
      <type value="group"/>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <linkId value="c11.2.1"/>
        <text value="Visit Type"/>
        <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="c11.2.1-help"/>
          <text
                value="Unique visit type, defined by the procedures which are completed within that visit.  E.g. Screening, Baseline, Followup, Final"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="c11.2.2"/>
        <text value="Visit Description"/>
        <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="c11.2.2-help"/>
          <text
                value="Description of Visit types, including what procedures it contains"/>
          <type value="display"/>
        </item>
      </item>
      <item>
        <linkId value="c11.2.3"/>
        <text value="Visit Duration"/>
        <type value="text"/>
        <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="c11.2.4"/>
        <text value="Visit Duration Units"/>
        <type value="choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system value="http://unitsofmeasure.org"/>
            <code value="min"/>
            <display value="min"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system value="http://unitsofmeasure.org"/>
            <code value="h"/>
            <display value="h"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system value="http://unitsofmeasure.org"/>
            <code value="d"/>
            <display value="d"/>
          </valueCoding>
        </answerOption>
      </item>
      <item>
        <linkId value="c11.2.5"/>
        <text value="Number of Visits"/>
        <type value="integer"/>
        <required value="false"/>
      </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="c11.3"/>
      <text value="Procedure List"/>
      <type value="group"/>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <linkId value="c11.3.1"/>
        <text value="Name of Procedure"/>
        <type value="string"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c11.3.2"/>
        <text value="Common Term of Procedure"/>
        <type value="string"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c11.3.3"/>
        <text value="Description of a Procedure"/>
        <type value="text"/>
        <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="c11.3.4"/>
        <text value="Experimental Procedure Indicator"/>
        <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>
      <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="c11.3.5"/>
        <text value="Research Indicator"/>
        <type value="choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="RES"/>
            <display value="Research"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="STDCR"/>
            <display value="Standard of Care"/>
          </valueCoding>
        </answerOption>
      </item>
      <item>
        <linkId value="c11.3.6"/>
        <text value="Frequency of Procedures"/>
        <type value="decimal"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c11.3.7"/>
        <text value="Procedure Duration (minutes)"/>
        <type value="decimal"/>
        <required value="false"/>
      </item>
    </item>
    <item>
      <linkId value="c11.4"/>
      <text value="Procedure Supplemental Text"/>
      <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="c11.4-help"/>
        <text
              value="Additional Text to include after the procedure table to provide the participant any additional information needed about procedure schedule"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c11.5"/>
      <text value="Total Duration of Study Participation"/>
      <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="c11.5-help"/>
        <text
              value="Time elapsed for a participant to be part of the study from initial enrollment to final discharge or completion"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c12"/>
    <text value="Risks"/>
    <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="gtable"/>
            <display value="Group Table"/>
          </coding>
          <text value="Group Table"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c12.1"/>
      <text value="Risk List"/>
      <type value="group"/>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <linkId value="c12.1.1"/>
        <text value="Name of the risk"/>
        <type value="string"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c12.1.2"/>
        <text value="Description of Risk"/>
        <type value="text"/>
        <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="c12.1.3"/>
        <text value="Risk Category"/>
        <type value="choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="PHYS"/>
            <display value="Physical"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="NONPHYS"/>
            <display value="Non-Physical"/>
          </valueCoding>
        </answerOption>
      </item>
    </item>
    <item>
      <linkId value="c12.2"/>
      <text value="Risk Supplemental Text"/>
      <type value="text"/>
      <required value="false"/>
      <item>
        <linkId value="c12.2_help"/>
        <text
              value="Additional text for description of other costs not directly associated with a risk"/>
        <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="c12.3"/>
      <definition value="9.4"/>
      <text value="Fetal Risks"/>
      <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="c12.3-help"/>
        <text value="Indicates whether risks to the fetus are possible"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c12.4"/>
      <text value="Fetal Risk Details"/>
      <type value="text"/>
      <enableWhen>
        <question value="c12.3"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c12.4-help"/>
        <text value="Textual description of risks to the fetus"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c13"/>
    <text value="Alternative Procedures"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c13.1"/>
      <text value="Alternative Procedure Text"/>
      <type value="text"/>
      <required value="false"/>
    </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="c14"/>
    <text value="Benefits"/>
    <type value="group"/>
    <required value="false"/>
    <repeats value="true"/>
    <item>
      <linkId value="c14.1"/>
      <text value="Name of Benefit"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="c14.2"/>
      <text value="Description of Benefit"/>
      <type value="text"/>
      <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="c14.3"/>
      <text value="Benefit to you"/>
      <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>
    <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="c14.4"/>
      <text value="Benefit to society"/>
      <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>
  </item>
  <item>
    <linkId value="c15"/>
    <text value="Compensation"/>
    <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="c15.1"/>
      <definition value="12.1"/>
      <text value="Will there be compensation for participation?"/>
      <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="c15.1-help"/>
        <text
              value="Indicates whether compensation will be offered or not for the study"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c15.2"/>
      <text value="Compensation Supplemental Text"/>
      <type value="text"/>
      <enableWhen>
        <question value="c15.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <item>
        <linkId value="c15.2_help"/>
        <text
              value="Additional text about compensation not captured in the compensation table"/>
        <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="c15.3"/>
      <text value="Compensation List"/>
      <type value="group"/>
      <enableWhen>
        <question value="c15.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <repeats value="true"/>
      <item>
        <linkId value="c15.3.1"/>
        <text
              value="What types of visits or milestones will I be compensated for?"/>
        <type value="text"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c15.3.2"/>
        <text
              value="How many visits or milestones of this type will there be compensation for?"/>
        <type value="integer"/>
        <required value="false"/>
      </item>
      <item>
        <linkId value="c15.3.3"/>
        <text value="How much will be paid per that type of visit?"/>
        <type value="text"/>
        <required value="false"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c16"/>
    <text value="Costs"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c16.1"/>
      <text value="What are the costs of participation, if any?"/>
      <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="c16.1-help"/>
        <text
              value="Explanation informing  participant if any additional costs will occur to the participant as a result of taking part in the 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="c16.2"/>
      <text
            value="Will there be reimbursement for other study visit costs incurred?"/>
      <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="c16.2-help"/>
        <text
              value="Reimbursement to participant for other study visit costs not directly associated with a visit"/>
        <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="c16.3"/>
      <text
            value="Who will pay for medical treatment if research related injury occurs?"/>
      <type value="choice"/>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="TRTNOTCOV"/>
          <display value="Treatment not covered"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="RRICOV"/>
          <display value="Research Related injury covered"/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="ACNOTCICOV"/>
          <display value="Acute but not chronic injury covered"/>
        </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="c16.3-help"/>
        <text
              value="Indicates if participant or the participant&#39;s insurance will be responsible for any injury which occurs or if the sponsor will cover any treatment costs for injury"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c16.4"/>
      <text value="Additional description of treatment coverage"/>
      <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="c16.4-help"/>
        <text
              value="Description of other costs not directly associated with a visit"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c17"/>
    <text value="Participant Rights and whom to contact for answers"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c17.1"/>
      <text value="What are the rights of a participant?"/>
      <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="c17.1-help"/>
        <text value="Statement of particpant rights"/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c17.2"/>
      <text value="Site IRB Contact Information"/>
      <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="c17.2-help"/>
        <text value="Contact information for the site IRB contact."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c17.3"/>
      <text value="Study Coordinator Contact Information"/>
      <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="c17.3-help"/>
        <text value="Contact information for the site IRB contact."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c17.4"/>
      <text value="Site Principal Investigator Contact Information"/>
      <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="c17.4-help"/>
        <text
              value="Contact information for the PI.  May be replicated from above."/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c18"/>
    <text value="Participation"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c18.1"/>
      <text value="Voluntary Permission Statement"/>
      <type value="text"/>
      <required value="false"/>
      <initial>
        <valueString
                     value="Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled."/>
      </initial>
      <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="c18.1-help"/>
        <text value="Standard prepopulated statement, can be edited."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c18.2"/>
      <text
            value="What are the anticipated circumstances under which participant&#39;s participation may be terminated by the investigator without regard to the participant&#39;s or the legally authorized representative&#39;s consent."/>
      <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="c18.2-help"/>
        <text
              value="Anticipated circumstances under which subject&#39;s participation may be terminated by  investigator without regard to  subject&#39;s or  legally authorized representative&#39;s consent"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c19"/>
    <text value="Early Withdrawal"/>
    <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="c19.1"/>
      <definition value="18.1"/>
      <text value="Are there consequences to participant for early withdrawal?"/>
      <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>
    <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="c19.2"/>
      <text value="Are there Emotional Consequences of Withdrawal"/>
      <type value="choice"/>
      <enableWhen>
        <question value="c19.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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="drop-down"/>
            <display value="Drop down"/>
          </coding>
          <text value="Drop down"/>
        </valueCodeableConcept>
      </extension>
      <linkId value="c19.3"/>
      <text value="Are there Physical Consequences of Withdrawal"/>
      <type value="choice"/>
      <enableWhen>
        <question value="c19.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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>
      <linkId value="c19.4"/>
      <text value="What are the consequences of withdrawal?"/>
      <type value="text"/>
      <enableWhen>
        <question value="c19.1"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c19.4-help"/>
        <text
              value="Description of the withdrawal consequences, will depend and vary based on type of study."/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c20"/>
    <text value="Confidentiality of Records"/>
    <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="c20.1"/>
      <definition value="19.2a"/>
      <text value="Will HIPAA content be included within this document?"/>
      <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>
    <item>
      <linkId value="c20.2"/>
      <text value="Medical information and billing statement"/>
      <type value="text"/>
      <enableWhen>
        <question value="c20.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <initial>
        <valueString
                     value="Medical information and billing records are protected by the privacy regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).  This type of information is called protected health information (PHI). PHI about you may be obtained from any hospital, doctor, and other health care provider involved in your care."/>
      </initial>
    </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="c20.3"/>
      <definition value="19.2"/>
      <text value="Will confidentiality be protected?"/>
      <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="c20.3-help"/>
        <text
              value="Indicates if records identifying a subject will be maintained."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c20.4"/>
      <text value="How will confidentiality be protected?"/>
      <type value="text"/>
      <enableWhen>
        <question value="c20.3"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c20.4-help"/>
        <text
              value="Explanation about processes and procedures to support maintaining privacy and confidentiality"/>
        <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="c20.5"/>
      <definition value="19.3"/>
      <text
            value="Are there data security or policies that need to be included in the consent, particularly around device use (optional)"/>
      <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="c20.5-help"/>
        <text
              value="Indicates if any data security policy applies to this consent, including device use."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c20.6"/>
      <text
            value="Describe any data security policies and processes protecting the data"/>
      <type value="text"/>
      <enableWhen>
        <question value="c20.5"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c20.6-help"/>
        <text
              value="Optional field for capturing information on IT related data security policies.  Example, use of encryption when utilizing mobile data collection"/>
        <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="c20.7"/>
      <text value="Who can use or see participant information?"/>
      <type value="group"/>
      <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="drop-down"/>
              <display value="Drop down"/>
            </coding>
            <text value="Drop down"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c20.7.1"/>
        <text value="Role or group who will have access to data"/>
        <type value="open-choice"/>
        <required value="false"/>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="OTHINSTRES"/>
            <display value="Researchers at other institutions"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="THISINSTRES"/>
            <display
                     value="Researchers outside the study team at this institution"/>
          </valueCoding>
        </answerOption>
        <answerOption>
          <valueCoding>
            <system
                    value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
            <code value="EXTREGAUTH"/>
            <display value="External Regulatory Authorities"/>
          </valueCoding>
        </answerOption>
      </item>
      <item>
        <linkId value="c20.7.2"/>
        <text value="Description of Information Disclosed"/>
        <type value="text"/>
        <required value="false"/>
      </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="c20.8"/>
      <definition value="19.5"/>
      <text value="Will the data be released for future use?"/>
      <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="c20.8-help"/>
        <text
              value="Indicates whether these data will be used beyond the study window"/>
        <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="c20.9"/>
      <definition value="19.5.1"/>
      <text value="Will the future use data be deidentified?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="c20.8"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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="c20.9-help"/>
        <text value="Indicates if shared data will retain any identifiers."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c20.10"/>
      <text value="Deidentification detail"/>
      <type value="text"/>
      <enableWhen>
        <question value="c20.9"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c20.10-help"/>
        <text
              value="Description of deidentification details for future use datasets. Two standardized statements, can be modified."/>
        <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="c20.11"/>
      <text value="Required text disclosure surrounding future use."/>
      <type value="choice"/>
      <enableWhen>
        <question value="c20.8"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </answerCoding>
      </enableWhen>
      <required value="false"/>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="DEIDUSED"/>
          <display
                   value="Identifiers might be removed from private information or biospecimens, and this information could then be used for future research studies or distributed to another investigator for future research studies without additional informed consent."/>
        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes"/>
          <code value="DEIDNOTUSED"/>
          <display
                   value="Information or biospecimens collected will not be used or distributed for future research studies, even if deidentified."/>
        </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="c20.11-help"/>
        <text
              value="Required Text disclosure surrounding future use of participant&#39;s data"/>
        <type value="display"/>
      </item>
    </item>
  </item>
  <item>
    <linkId value="c21"/>
    <text value="Specimen Management"/>
    <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="c21.1"/>
      <definition value="20.1"/>
      <text value="Were specimens collected as part of this study?"/>
      <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>
    <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="c21.2"/>
      <text value="Is whole genome sequencing being conducted?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="c21.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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="c21.2-help"/>
        <text
              value="Indicator of if genome sequencing is being conducted in conjunction with 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="c21.3"/>
      <definition value="20.1.4"/>
      <text value="Sharing or no Sharing of samples."/>
      <type value="choice"/>
      <enableWhen>
        <question value="c21.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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="c21.3-help"/>
        <text
              value="Indicator of whether biospecimens will be shared outside of the immediate study team or institution."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c21.4"/>
      <text value="Conditions of sharing"/>
      <type value="text"/>
      <enableWhen>
        <question value="c21.3"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c21.4-help"/>
        <text
              value="Textual description of sharing conditions including, type, when, etc."/>
        <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="c21.5"/>
      <text value="Will participant share in profit with commerical use?"/>
      <type value="choice"/>
      <enableWhen>
        <question value="c21.1"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
        </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="c21.5-help"/>
        <text
              value="Indicator of any plans to profit share any funds received as a result of commercial use of those samples."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c21.6"/>
      <text value="Description of Collection and Storage"/>
      <type value="text"/>
      <enableWhen>
        <question value="c21.1"/>
        <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="help"/>
              <display value="Help-Button"/>
            </coding>
            <text value="Help-Button"/>
          </valueCodeableConcept>
        </extension>
        <linkId value="c21.6-help"/>
        <text
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        <type value="display"/>
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    <item>
      <extension
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        <valueCodeableConcept>
          <coding>
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            <code value="drop-down"/>
            <display value="Drop down"/>
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          <text value="Drop down"/>
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      </extension>
      <linkId value="c21.7"/>
      <text value="Can consent for sample use be revoked?"/>
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        <question value="c21.1"/>
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              <display value="Help-Button"/>
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            <text value="Help-Button"/>
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        <linkId value="c21.7-help"/>
        <text value="Indicator of revocation of sample consent is an option"/>
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  <item>
    <extension
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          <display value="Drop down"/>
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        <text value="Drop down"/>
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    <linkId value="c22"/>
    <definition value="21"/>
    <text
          value="Will there be Broad Consent for Storage, maintenance and secondary research use?"/>
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        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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        <display value="No"/>
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    <item>
      <linkId value="c22.1"/>
      <text
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        <question value="c22"/>
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          <code value="Y"/>
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    <extension
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      <valueCodeableConcept>
        <coding>
          <system value="http://hl7.org/fhir/questionnaire-item-control"/>
          <code value="drop-down"/>
          <display value="Drop down"/>
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        <text value="Drop down"/>
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    <linkId value="c23"/>
    <definition value="22"/>
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    <answerOption>
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    <item>
      <linkId value="c23.1"/>
      <text
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        <question value="c23"/>
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      <required value="false"/>
      <item>
        <extension
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          <valueCodeableConcept>
            <coding>
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              <code value="help"/>
              <display value="Help-Button"/>
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            <text value="Help-Button"/>
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        <linkId value="c23.1-help"/>
        <text
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        <type value="display"/>
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    <item>
      <extension
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        <valueCodeableConcept>
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          <text value="Help-Button"/>
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      <linkId value="c23-help"/>
      <text
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  <item>
    <extension
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      <valueCodeableConcept>
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          <code value="drop-down"/>
          <display value="Drop down"/>
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        <text value="Drop down"/>
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    <linkId value="c24"/>
    <definition value="23"/>
    <text value="Will participants share in commercial profit?"/>
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      <valueCoding>
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    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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        <display value="No"/>
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    <item>
      <linkId value="c24.1"/>
      <text
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      <type value="text"/>
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        <question value="c24"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
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      <required value="false"/>
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    <item>
      <extension
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        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
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          <text value="Help-Button"/>
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      <linkId value="c24-help"/>
      <text
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      <type value="display"/>
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  <item>
    <extension
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      <valueCodeableConcept>
        <coding>
          <system value="http://hl7.org/fhir/questionnaire-item-control"/>
          <code value="drop-down"/>
          <display value="Drop down"/>
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        <text value="Drop down"/>
      </valueCodeableConcept>
    </extension>
    <linkId value="c25"/>
    <text
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    <required value="false"/>
    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
        <code value="N"/>
        <display value="No"/>
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    <item>
      <extension
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        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
            <code value="help"/>
            <display value="Help-Button"/>
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          <text value="Help-Button"/>
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      <linkId value="c25-help"/>
      <text
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      <type value="display"/>
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  <item>
    <extension
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      <valueCodeableConcept>
        <coding>
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          <code value="drop-down"/>
          <display value="Drop down"/>
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        <text value="Drop down"/>
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    <linkId value="c26"/>
    <definition value="25"/>
    <text
          value="Will the study team disclose clinically relevant study results to you?"/>
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    <required value="false"/>
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      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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    <answerOption>
      <valueCoding>
        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
        <code value="N"/>
        <display value="No"/>
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    <item>
      <linkId value="c26.1"/>
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        <question value="c26"/>
        <operator value="="/>
        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="Y"/>
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      <required value="false"/>
      <item>
        <extension
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          <valueCodeableConcept>
            <coding>
              <system value="http://hl7.org/fhir/questionnaire-item-control"/>
              <code value="help"/>
              <display value="Help-Button"/>
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            <text value="Help-Button"/>
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        <linkId value="c26.1-help"/>
        <text
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        <type value="display"/>
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    <item>
      <extension
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        <valueCodeableConcept>
          <coding>
            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
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            <display value="Help-Button"/>
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          <text value="Help-Button"/>
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      </extension>
      <linkId value="c26-help"/>
      <text
            value="Indicator of  study team will provide results of lab tests or other feedback of results to you at any time."/>
      <type value="display"/>
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  </item>
  <item>
    <linkId value="c27"/>
    <text value="Clinical Trials.gov statement"/>
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    <readOnly value="true"/>
    <initial>
      <valueString
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  <item>
    <extension
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      <valueCodeableConcept>
        <coding>
          <system value="http://hl7.org/fhir/questionnaire-item-control"/>
          <code value="drop-down"/>
          <display value="Drop down"/>
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        <text value="Drop down"/>
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    <linkId value="c28"/>
    <definition value="26"/>
    <text
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        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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        <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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        <question value="c28"/>
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        <answerCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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      <required value="false"/>
      <readOnly value="true"/>
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        <valueString
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      <item>
        <extension
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          <valueCodeableConcept>
            <coding>
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        <linkId value="c28.1-help"/>
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    <item>
      <linkId value="c28.2"/>
      <text value="Required Disclosures based on state law"/>
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        <question value="c28"/>
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        <answerCoding>
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      <required value="false"/>
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    <linkId value="c29"/>
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      <extension
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        <valueCodeableConcept>
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            <system value="http://hl7.org/fhir/questionnaire-item-control"/>
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          <text value="Help-Button"/>
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      <linkId value="c29-help"/>
      <text
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  <item>
    <linkId value="c30"/>
    <text value="Statement of PHI Authorization Revocation"/>
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      <valueString
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  <item>
    <linkId value="c31"/>
    <text value="Signature"/>
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    <required value="false"/>
    <item>
      <extension
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        <valueCodeableConcept>
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      <linkId value="c31.1"/>
      <text value="Indicator to include Participant Signature and Date/Time"/>
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        <valueCoding>
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    <item>
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          <text value="Drop down"/>
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      <linkId value="c31.2"/>
      <text value="Indicator to include Assent Signature and Date/Time"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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      <answerOption>
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    <item>
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          <text value="Drop down"/>
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      <linkId value="c31.3"/>
      <text
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        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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    <item>
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          <text value="Drop down"/>
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      <linkId value="c31.4"/>
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        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
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          <display value="Spouse"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
          <code value="CHD"/>
          <display value="Child"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
          <code value="SIB"/>
          <display value="Sibling"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
          <code value="GRD"/>
          <display value="Guardian"/>
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      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0063"/>
          <code value="OTH"/>
          <display value="Other"/>
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    <item>
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      <linkId value="c31.5"/>
      <text value="Indicator to include a Witness Signature and Date/Time"/>
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          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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      <answerOption>
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    <item>
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      <linkId value="c31.6"/>
      <text value="Indicator to include Parent 1 Signature and Date/Time"/>
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          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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      <answerOption>
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    <item>
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      <linkId value="c31.7"/>
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          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
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        </valueCoding>
      </answerOption>
      <answerOption>
        <valueCoding>
          <system value="http://terminology.hl7.org/CodeSystem/v2-0532"/>
          <code value="N"/>
          <display value="No"/>
        </valueCoding>
      </answerOption>
    </item>
  </item>
  <item>
    <linkId value="c32"/>
    <text value="Protocol or Study Number"/>
    <type value="group"/>
    <required value="false"/>
    <item>
      <linkId value="c32.1"/>
      <text value="IRB Number"/>
      <type value="string"/>
      <required value="false"/>
    </item>
    <item>
      <linkId value="c32.2"/>
      <text value="sIRB Version Date of  Consent"/>
      <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="c32.2-help"/>
        <text
              value="Date that changes whenever a change is made to the consent.  It is the versioning system of the sIRB institution, and is updated in accordance with the institution&#39;s policy."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c32.3"/>
      <text value="Relying Site Version Date of Consent"/>
      <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="c32.3-help"/>
        <text
              value="A number that changes whenever a change is made to the consent.  It is the versioning system of the relying institution, and is updated in accordance with the institution&#39;s policy."/>
        <type value="display"/>
      </item>
    </item>
    <item>
      <linkId value="c32.6"/>
      <text value="Expiration Date of Consent"/>
      <type value="dateTime"/>
      <required value="false"/>
    </item>
  </item>
  <item>
    <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="c"/>
      </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, 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="ADMIN04"/>
      <text
            value="Questionnaire Response ID of the local considerations Questionnaire Response, if any"/>
      <type value="string"/>
      <required value="false"/>
    </item>
  </item>
</Questionnaire>