Profile_R5_ResearchStudy_R4B - XML Representation - Extensions for Using Data Elements from FHIR R5 in FHIR R4B v0.1.0

Extensions for Using Data Elements from FHIR R5 in FHIR R4B - Downloaded Version null See the Directory of published versions
Resource Profile: Profile_R5_ResearchStudy_R4B - XML Profile

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XML representation of the profile-ResearchStudy resource profile.
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<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="profile-ResearchStudy"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition profile-ResearchStudy</b></p><a name="profile-ResearchStudy"> </a><a name="hcprofile-ResearchStudy"> </a><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the element can appear in the instance">Card.</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px; width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; padding-top: 3px; padding-bottom: 3px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy">ResearchStudy</a><a name="ResearchStudy"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/researchstudy.html">ResearchStudy(4.3.0)</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Investigation to increase healthcare-related patient-independent knowledge</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck13.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension">Slices for extension</a><a name="ResearchStudy.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:url" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url">extension:url</a><a name="ResearchStudy.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Canonical identifier for this study resource (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.url.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:version" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version">extension:version</a><a name="ResearchStudy.extension.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: The business version for the study record (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.version.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:name" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name">extension:name</a><a name="ResearchStudy.extension.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Name for this study (computer friendly) (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.name.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:label" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label">extension:label</a><a name="ResearchStudy.extension.5"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Additional names for the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.label.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:date" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date">extension:date</a><a name="ResearchStudy.extension.6"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#dateTime">dateTime</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Date the resource last changed (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.date.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:studyDesign" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign">extension:studyDesign</a><a name="ResearchStudy.extension.7"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Classifications of the study design characteristics (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.studyDesign.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R5-study-design-for-R4B.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R5-study-design-for-R4B" class="binding">R5StudyDesignForR4B (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R4B/terminologies.html#preferred" title="Instances are encouraged to draw from the specified codes for interoperability purposes but are not required to do so to be considered conformant." class="binding">preferred</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">This is a set of terms for study design characteristics.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:descriptionSummary" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary">extension:descriptionSummary</a><a name="ResearchStudy.extension.8"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Brief text explaining the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.descriptionSummary.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:classifier" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier">extension:classifier</a><a name="ResearchStudy.extension.9"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#CodeableConcept">CodeableConcept</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Classification for the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.classifier.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R5-research-study-classifiers-for-R4B.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R5-research-study-classifiers-for-R4B" class="binding">R5ResearchStudyClassifiersForR4B (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R4B/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set.  The value set merely provides examples of the types of concepts intended to be included." class="binding">example</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">desc.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:associatedParty" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty">extension:associatedParty</a><a name="ResearchStudy.extension.10"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Sponsors, collaborators, and other parties (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.associatedParty.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:progressStatus" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus">extension:progressStatus</a><a name="ResearchStudy.extension.11"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Status of study with time for that status (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.progressStatus.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:targetNumber" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber">extension:targetNumber</a><a name="ResearchStudy.extension.12"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#unsignedInt">unsignedInt</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Estimated total number of participants to be enrolled (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.rec.targetNumber.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:actualNumber" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber">extension:actualNumber</a><a name="ResearchStudy.extension.13"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#unsignedInt">unsignedInt</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Actual total number of participants enrolled in study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.rec.actualNumber.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:actualGroup" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup">extension:actualGroup</a><a name="ResearchStudy.extension.14"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="StructureDefinition-profile-Group.html">Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/group.html">Group</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Group of participants who were enrolled in study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.rec.actualGroup.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck134.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:outcomeMeasure" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure">extension:outcomeMeasure</a><a name="ResearchStudy.extension.15"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">(Complex)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: A variable measured during the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.outcomeMeasure.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck124.png)" class="hierarchy"><img src="tbl_spacer.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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.extension:result" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result">extension:result</a><a name="ResearchStudy.extension.16"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="StructureDefinition-profile-EvidenceReport.html">Cross-version Profile for R5.EvidenceReport for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/evidencereport.html">EvidenceReport</a> | <a href="StructureDefinition-profile-Citation.html">Cross-version Profile for R5.Citation for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/citation.html">Citation</a> | <a href="StructureDefinition-profile-DiagnosticReport.html">Cross-version Profile for R5.DiagnosticReport for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/diagnosticreport.html">DiagnosticReport</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Link to results generated during the study (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.result.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status">status</a><a name="ResearchStudy.status"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.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_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status.extension">Slices for extension</a><a name="ResearchStudy.status.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.status.extension:status" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status">extension:status</a><a name="ResearchStudy.status.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: draft | active | retired | unknown additional codes<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.status.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="http://hl7.org/fhir/R4B/valueset-publication-status.html" title="http://hl7.org/fhir/ValueSet/publication-status" class="binding">PublicationStatus</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R4B/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set." class="binding">required</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">Codes that convey the current publication status of the research study resource.</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.focus">focus</a><a name="ResearchStudy.focus"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.focus.extension">Slices for extension</a><a name="ResearchStudy.focus.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.focus.extension:focus" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus">extension:focus</a><a name="ResearchStudy.focus.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">CodeableReference</a>(<a href="StructureDefinition-profile-Medication.html">Cross-version Profile for R5.Medication for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/medication.html">Medication</a> | <a href="StructureDefinition-profile-MedicinalProductDefinition.html">Cross-version Profile for R5.MedicinalProductDefinition for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/medicinalproductdefinition.html">MedicinalProductDefinition</a> | <a href="StructureDefinition-profile-SubstanceDefinition.html">Cross-version Profile for R5.SubstanceDefinition for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/substancedefinition.html">SubstanceDefinition</a> | <a href="StructureDefinition-profile-EvidenceVariable.html">Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/evidencevariable.html">EvidenceVariable</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: focus additional types<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.focus.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus</a><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-R5-research-study-focus-type-for-R4B.html" title="http://hl7.org/fhir/uv/xver/ValueSet/R5-research-study-focus-type-for-R4B" class="binding">R5ResearchStudyFocusTypeForR4B (0.1.0)</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R4B/terminologies.html#example" title="Instances are not expected or even encouraged to draw from the specified value set.  The value set merely provides examples of the types of concepts intended to be included." class="binding">example</a><span title="null" class="binding">)</span><span title="null" class="binding">: </span><span title="null" class="binding">Common codes of research study focus</span><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.enrollment">enrollment</a><a name="ResearchStudy.enrollment"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.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_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.enrollment.extension">Slices for extension</a><a name="ResearchStudy.enrollment.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.enrollment.extension:eligibility" title="Extension URL = http://hl7.org/fhir/StructureDefinition/alternate-reference">extension:eligibility</a><a name="ResearchStudy.enrollment.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="http://hl7.org/fhir/R4B/resource.html">Resource</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Inclusion and exclusion criteria additional types<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/extensions/5.2.0/StructureDefinition-alternate-reference.html">http://hl7.org/fhir/StructureDefinition/alternate-reference</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.site">site</a><a name="ResearchStudy.site"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.site.extension">Slices for extension</a><a name="ResearchStudy.site.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.site.extension:site" title="Extension URL = http://hl7.org/fhir/StructureDefinition/alternate-reference">extension:site</a><a name="ResearchStudy.site.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="http://hl7.org/fhir/R4B/resource.html">Resource</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: site<br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/extensions/5.2.0/StructureDefinition-alternate-reference.html">http://hl7.org/fhir/StructureDefinition/alternate-reference</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #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_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.arm">arm</a><a name="ResearchStudy.arm"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck103.png)" class="hierarchy"><img src="tbl_spacer.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_extension_simple.png" alt="." style="background-color: white; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.arm.extension">Slices for extension</a><a name="ResearchStudy.arm.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1034.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.arm.extension:linkId" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId">extension:linkId</a><a name="ResearchStudy.arm.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#id">id</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.com.linkId.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1034.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.arm.extension:intendedExposure" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure">extension:intendedExposure</a><a name="ResearchStudy.arm.extension.3"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="StructureDefinition-profile-EvidenceVariable.html">Cross-version Profile for R5.EvidenceVariable for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/evidencevariable.html">EvidenceVariable</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Interventions or exposures in this comparisonGroup or cohort (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.com.intendedExposure.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1024.png)" class="hierarchy"><img src="tbl_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_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.arm.extension:observedGroup" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup">extension:observedGroup</a><a name="ResearchStudy.arm.extension.4"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/references.html">Reference</a>(<a href="StructureDefinition-profile-Group.html">Cross-version Profile for R5.Group for use in FHIR R4B(0.1.0)</a> | <a href="http://hl7.org/fhir/R4B/group.html">Group</a>)</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Group of participants who were enrolled in study comparisonGroup (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.com.observedGroup.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup</a><br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.objective">objective</a><a name="ResearchStudy.objective"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck003.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_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.objective.extension">Slices for extension</a><a name="ResearchStudy.objective.extension"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R4B/extensibility.html#Extension">Extension</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck0024.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_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end_slicer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-profile-ResearchStudy-definitions.html#ResearchStudy.objective.extension:description" title="Extension URL = http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description">extension:description</a><a name="ResearchStudy.objective.extension.2"> </a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">R5: Description of the objective (new)<br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-ext-R5-ResearchStudy.obj.description.html">http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description</a><br/></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="fhir"/>
  </extension>
  <extension url="http://hl7.org/fhir/StructureDefinition/package-source">
    <extension url="packageId">
      <valueId value="hl7.fhir.uv.xver-r5.r4b"/>
    </extension>
    <extension url="version">
      <valueString value="0.1.0"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="0">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4b"/>
      </extension>
    </valueInteger>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/uv/xver/ImplementationGuide/hl7.fhir.uv.xver-r5.r4b"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/5.0/StructureDefinition/profile-ResearchStudy"/>
  <version value="0.1.0"/>
  <name value="Profile_R5_ResearchStudy_R4B"/>
  <title
         value="Cross-version Profile for R5.ResearchStudy for use in FHIR R4B"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2026-03-17T16:03:55.0630213-05:00"/>
  <publisher value="FHIR Infrastructure"/>
  <contact>
    <name value="FHIR Infrastructure"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/fiwg"/>
    </telecom>
  </contact>
  <description
               value="This cross-version profile allows R5 ResearchStudy content to be represented via FHIR R4B ResearchStudy resources."/>
  <jurisdiction>
    <coding>
      <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
      <code value="001"/>
      <display value="World"/>
    </coding>
  </jurisdiction>
  <fhirVersion value="4.3.0"/>
  <mapping>
    <identity value="BRIDG5.1"/>
    <uri value="https://bridgmodel.nci.nih.gov"/>
    <name value="BRIDG 5.1 Mapping"/>
  </mapping>
  <mapping>
    <identity value="v2"/>
    <uri value="http://hl7.org/v2"/>
    <name value="HL7 v2 Mapping"/>
  </mapping>
  <mapping>
    <identity value="rim"/>
    <uri value="http://hl7.org/v3"/>
    <name value="RIM Mapping"/>
  </mapping>
  <mapping>
    <identity value="w5"/>
    <uri value="http://hl7.org/fhir/fivews"/>
    <name value="FiveWs Pattern Mapping"/>
  </mapping>
  <mapping>
    <identity value="clinicaltrials-gov"/>
    <uri value="http://clinicaltrials.gov"/>
    <name value="ClinicalTrials.gov Mapping"/>
  </mapping>
  <kind value="resource"/>
  <abstract value="false"/>
  <type value="ResearchStudy"/>
  <baseDefinition
                  value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.3.0"/>
  <derivation value="constraint"/>
  <snapshot>
    <extension
               url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
      <valueString value="4.3.0"/>
    </extension>
    <element id="ResearchStudy">
      <path value="ResearchStudy"/>
      <short
             value="Investigation to increase healthcare-related patient-independent knowledge"/>
      <definition
                  value="A process where a researcher or organization plans and then executes a series of steps intended to increase the field of healthcare-related knowledge.  This includes studies of safety, efficacy, comparative effectiveness and other information about medications, devices, therapies and other interventional and investigative techniques.  A ResearchStudy involves the gathering of information about human or animal subjects."/>
      <comment value="Need to make sure we encompass public health studies."/>
      <alias value="Clinical Trial"/>
      <alias value="Study"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <constraint>
        <key value="dom-2"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
        <expression value="contained.contained.empty()"/>
        <xpath value="not(parent::f:contained and f:contained)"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"/>
      </constraint>
      <constraint>
        <key value="dom-3"/>
        <severity value="error"/>
        <human
               value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
        <expression
                    value="contained.where(((id.exists() and ('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url)))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(uri) = '#').exists()).not()).trace('unmatched', id).empty()"/>
        <xpath
               value="not(exists(for $contained in f:contained return $contained[not(exists(parent::*/descendant::f:reference/@value=concat('#', $contained/*/f:id/@value)) or exists(descendant::f:reference[@value='#']))]))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"/>
      </constraint>
      <constraint>
        <key value="dom-4"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
        <expression
                    value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
        <xpath
               value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"/>
      </constraint>
      <constraint>
        <key value="dom-5"/>
        <severity value="error"/>
        <human
               value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
        <expression value="contained.meta.security.empty()"/>
        <xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"/>
      </constraint>
      <constraint>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
          <valueBoolean value="true"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
          <valueMarkdown
                         value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
        </extension>
        <key value="dom-6"/>
        <severity value="warning"/>
        <human
               value="A resource should have narrative for robust management"/>
        <expression value="text.`div`.exists()"/>
        <xpath value="exists(f:text/h:div)"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/DomainResource|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Entity. Role, or Act"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="ObservationalStudyProtocolVersion; Study;
StudyProtocolVersion"/>
      </mapping>
      <mapping>
        <identity value="v2"/>
        <map value="OBX"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="clinical.diagnostics"/>
      </mapping>
    </element>
    <element id="ResearchStudy.id">
      <path value="ResearchStudy.id"/>
      <short value="Logical id of this artifact"/>
      <definition
                  value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
      <comment
               value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.meta">
      <path value="ResearchStudy.meta"/>
      <short value="Metadata about the resource"/>
      <definition
                  value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.meta"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Meta"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.implicitRules">
      <path value="ResearchStudy.implicitRules"/>
      <short value="A set of rules under which this content was created"/>
      <definition
                  value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
      <comment
               value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.implicitRules"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
      <isSummary value="true"/>
    </element>
    <element id="ResearchStudy.language">
      <path value="ResearchStudy.language"/>
      <short value="Language of the resource content"/>
      <definition
                  value="The base language in which the resource is written."/>
      <comment
               value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies  to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Resource.language"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
          <valueCanonical
                          value="http://hl7.org/fhir/ValueSet/all-languages|4.3.0"/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Language"/>
        </extension>
        <strength value="preferred"/>
        <description value="IETF language tag"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/languages|4.3.0"/>
      </binding>
    </element>
    <element id="ResearchStudy.text">
      <path value="ResearchStudy.text"/>
      <short value="Text summary of the resource, for human interpretation"/>
      <definition
                  value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment
               value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="Act.text?"/>
      </mapping>
    </element>
    <element id="ResearchStudy.contained">
      <path value="ResearchStudy.contained"/>
      <short value="Contained, inline Resources"/>
      <definition
                  value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
      <comment
               value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
      <alias value="inline resources"/>
      <alias value="anonymous resources"/>
      <alias value="contained resources"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.contained"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Resource"/>
      </type>
      <constraint>
        <key value="dom-r4b"/>
        <severity value="warning"/>
        <human
               value="Containing new R4B resources within R4 resources may cause interoperability issues if instances are shared with R4 systems"/>
        <expression
                    value="($this is Citation or $this is Evidence or $this is EvidenceReport or $this is EvidenceVariable or $this is MedicinalProductDefinition or $this is PackagedProductDefinition or $this is AdministrableProductDefinition or $this is Ingredient or $this is ClinicalUseDefinition or $this is RegulatedAuthorization or $this is SubstanceDefinition or $this is SubscriptionStatus or $this is SubscriptionTopic) implies (%resource is Citation or %resource is Evidence or %resource is EvidenceReport or %resource is EvidenceVariable or %resource is MedicinalProductDefinition or %resource is PackagedProductDefinition or %resource is AdministrableProductDefinition or %resource is Ingredient or %resource is ClinicalUseDefinition or %resource is RegulatedAuthorization or %resource is SubstanceDefinition or %resource is SubscriptionStatus or %resource is SubscriptionTopic)"/>
        <xpath
               value="not(f:Citation|f:Evidence|f:EvidenceReport|f:EvidenceVariable|f:MedicinalProductDefinition|f:PackagedProductDefinition|f:AdministrableProductDefinition|f:Ingredient|f:ClinicalUseDefinition|f:RegulatedAuthorization|f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic) or not(parent::f:Citation|parent::f:Evidence|parent::f:EvidenceReport|parent::f:EvidenceVariable|parent::f:MedicinalProductDefinition|parent::f:PackagedProductDefinition|parent::f:AdministrableProductDefinition|parent::f:Ingredient|parent::f:ClinicalUseDefinition|parent::f:RegulatedAuthorization|parent::f:SubstanceDefinition|f:SubscriptionStatus|f:SubscriptionTopic)"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.extension">
      <path value="ResearchStudy.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:url">
      <path value="ResearchStudy.extension"/>
      <sliceName value="url"/>
      <short value="R5: Canonical identifier for this study resource (new)"/>
      <definition value="R5: `ResearchStudy.url` (new:uri)"/>
      <comment
               value="Element `ResearchStudy.url` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.url` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:version">
      <path value="ResearchStudy.extension"/>
      <sliceName value="version"/>
      <short value="R5: The business version for the study record (new)"/>
      <definition value="R5: `ResearchStudy.version` (new:string)"/>
      <comment
               value="Element `ResearchStudy.version` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.version` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:name">
      <path value="ResearchStudy.extension"/>
      <sliceName value="name"/>
      <short value="R5: Name for this study (computer friendly) (new)"/>
      <definition value="R5: `ResearchStudy.name` (new:string)"/>
      <comment
               value="Element `ResearchStudy.name` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.name` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:label">
      <path value="ResearchStudy.extension"/>
      <sliceName value="label"/>
      <short value="R5: Additional names for the study (new)"/>
      <definition value="R5: `ResearchStudy.label` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.label` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.label` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:date">
      <path value="ResearchStudy.extension"/>
      <sliceName value="date"/>
      <short value="R5: Date the resource last changed (new)"/>
      <definition value="R5: `ResearchStudy.date` (new:dateTime)"/>
      <comment
               value="Element `ResearchStudy.date` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.date` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:studyDesign">
      <path value="ResearchStudy.extension"/>
      <sliceName value="studyDesign"/>
      <short
             value="R5: Classifications of the study design characteristics (new)"/>
      <definition
                  value="R5: `ResearchStudy.studyDesign` (new:CodeableConcept)"/>
      <comment
               value="Element `ResearchStudy.studyDesign` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.studyDesign` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:descriptionSummary">
      <path value="ResearchStudy.extension"/>
      <sliceName value="descriptionSummary"/>
      <short value="R5: Brief text explaining the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.descriptionSummary` (new:markdown)"/>
      <comment
               value="Element `ResearchStudy.descriptionSummary` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.descriptionSummary` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:classifier">
      <path value="ResearchStudy.extension"/>
      <sliceName value="classifier"/>
      <short value="R5: Classification for the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.classifier` (new:CodeableConcept)"/>
      <comment
               value="Element `ResearchStudy.classifier` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.classifier` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:associatedParty">
      <path value="ResearchStudy.extension"/>
      <sliceName value="associatedParty"/>
      <short value="R5: Sponsors, collaborators, and other parties (new)"/>
      <definition
                  value="R5: `ResearchStudy.associatedParty` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.associatedParty` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.associatedParty` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).
For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:progressStatus">
      <path value="ResearchStudy.extension"/>
      <sliceName value="progressStatus"/>
      <short value="R5: Status of study with time for that status (new)"/>
      <definition
                  value="R5: `ResearchStudy.progressStatus` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.progressStatus` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.progressStatus` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:targetNumber">
      <path value="ResearchStudy.extension"/>
      <sliceName value="targetNumber"/>
      <short
             value="R5: Estimated total number of participants to be enrolled (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.targetNumber` (new:unsignedInt)"/>
      <comment
               value="Element `ResearchStudy.recruitment.targetNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.targetNumber` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:actualNumber">
      <path value="ResearchStudy.extension"/>
      <sliceName value="actualNumber"/>
      <short
             value="R5: Actual total number of participants enrolled in study (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.actualNumber` (new:unsignedInt)"/>
      <comment
               value="Element `ResearchStudy.recruitment.actualNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.actualNumber` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:actualGroup">
      <path value="ResearchStudy.extension"/>
      <sliceName value="actualGroup"/>
      <short
             value="R5: Group of participants who were enrolled in study (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.actualGroup` (new:Reference(Group))"/>
      <comment
               value="Element `ResearchStudy.recruitment.actualGroup` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.actualGroup` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:outcomeMeasure">
      <path value="ResearchStudy.extension"/>
      <sliceName value="outcomeMeasure"/>
      <short value="R5: A variable measured during the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.outcomeMeasure` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.outcomeMeasure` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.outcomeMeasure` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).
A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.extension:result">
      <path value="ResearchStudy.extension"/>
      <sliceName value="result"/>
      <short value="R5: Link to results generated during the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.result` (new:Reference(EvidenceReport,Citation,DiagnosticReport))"/>
      <comment
               value="Element `ResearchStudy.result` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.result` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.modifierExtension">
      <path value="ResearchStudy.modifierExtension"/>
      <short value="Extensions that cannot be ignored"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.identifier">
      <path value="ResearchStudy.identifier"/>
      <short value="Business Identifier for study"/>
      <definition
                  value="Identifiers assigned to this research study by the sponsor or other systems."/>
      <requirements
                    value="Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.identifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Organization's Unique Protocol ID; Secondary IDs"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  DocumentVersion.identifier &gt; StudyProtocolDocumentVersion, this is arguably a different semantic)"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.title">
      <path value="ResearchStudy.title"/>
      <short value="Name for this study"/>
      <definition
                  value="A short, descriptive user-friendly label for the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.title"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Brief Title"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (although there is  StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)"/>
      </mapping>
    </element>
    <element id="ResearchStudy.protocol">
      <path value="ResearchStudy.protocol"/>
      <short value="Steps followed in executing study"/>
      <definition
                  value="The set of steps expected to be performed as part of the execution of the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.protocol"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/PlanDefinition|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Interventions; Arm/Intervention Cross-Reference"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocumentVersionPublicTitle.name"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".outboundRelationship[typeCode=DEFN].target"/>
      </mapping>
    </element>
    <element id="ResearchStudy.partOf">
      <path value="ResearchStudy.partOf"/>
      <short value="Part of larger study"/>
      <definition
                  value="A larger research study of which this particular study is a component or step."/>
      <requirements
                    value="Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc."/>
      <alias value="container"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.partOf"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="CompanionStudyRelationship"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".inboundRelationship[typeCode=COMP].source[moodCode=EVN]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.status">
      <path value="ResearchStudy.status"/>
      <short
             value="active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn"/>
      <definition value="The current state of the study."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.status"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="true"/>
      <isModifierReason
                        value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyStatus"/>
        </extension>
        <strength value="required"/>
        <description
                     value="Codes that convey the current status of the research study."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-status|4.3.0"/>
      </binding>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.status"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyOverallStatus.code"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".status"/>
      </mapping>
    </element>
    <element id="ResearchStudy.status.id">
      <path value="ResearchStudy.status.id"/>
      <representation value="xmlAttr"/>
      <short value="xml:id (or equivalent in JSON)"/>
      <definition
                  value="unique id for the element within a resource (for internal references)"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.status.extension">
      <path value="ResearchStudy.status.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.status.extension:status">
      <path value="ResearchStudy.status.extension"/>
      <sliceName value="status"/>
      <short value="R5: draft | active | retired | unknown additional codes"/>
      <definition value="R5: `ResearchStudy.status` additional codes"/>
      <comment
               value="Element `ResearchStudy.status` is mapped to FHIR R4B element `ResearchStudy.status` as `RelatedTo`.
The mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target.
The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.status.value">
      <path value="ResearchStudy.status.value"/>
      <representation value="xmlAttr"/>
      <short value="Primitive value for code"/>
      <definition value="Primitive value for code"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="string.value"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="code"/>
        </extension>
        <extension url="http://hl7.org/fhir/StructureDefinition/regex">
          <valueString value="[^\s]+(\s[^\s]+)*"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.primaryPurposeType">
      <path value="ResearchStudy.primaryPurposeType"/>
      <short
             value="treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility"/>
      <definition
                  value="The type of study based upon the intent of the study's activities. A classification of the intent of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.primaryPurposeType"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPrimaryPurposeType"/>
        </extension>
        <strength value="extensible"/>
        <description value="Codes for the main intent of the study."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|4.3.0"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.primaryPurposeTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.phase">
      <path value="ResearchStudy.phase"/>
      <short
             value="n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4"/>
      <definition
                  value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.phase"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyPhase"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-phase|4.3.0"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Study Phase"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.phaseCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.category">
      <path value="ResearchStudy.category"/>
      <short value="Classifications for the study"/>
      <definition
                  value="Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.category"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyCategory"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Codes that describe the type of research study.  E.g. Study phase, Interventional/Observational, blinding type, etc."/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.focus">
      <path value="ResearchStudy.focus"/>
      <short value="Drugs, devices, etc. under study"/>
      <definition
                  value="The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.focus"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyFocus"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Codes for medications, devices and other interventions."/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Focus of Study"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="InterventionalStudyProtocol.interventionTypeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.focus.id">
      <path value="ResearchStudy.focus.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.focus.extension">
      <path value="ResearchStudy.focus.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.focus.extension:focus">
      <path value="ResearchStudy.focus.extension"/>
      <sliceName value="focus"/>
      <short value="R5: focus additional types"/>
      <definition
                  value="R5: `ResearchStudy.focus` additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))"/>
      <comment
               value="Element `ResearchStudy.focus` is mapped to FHIR R4B element `ResearchStudy.focus` as `SourceIsBroaderThanTarget`.
The mappings for `ResearchStudy.focus` do not cover the following types: CodeableReference."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus|0.1.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.focus.coding">
      <path value="ResearchStudy.focus.coding"/>
      <short value="Code defined by a terminology system"/>
      <definition
                  value="A reference to a code defined by a terminology system."/>
      <comment
               value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information.  Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/>
      <requirements
                    value="Allows for alternative encodings within a code system, and translations to other code systems."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="CodeableConcept.coding"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Coding"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.1-8, C*E.10-22"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value="union(., ./translation)"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/>
      </mapping>
    </element>
    <element id="ResearchStudy.focus.text">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ResearchStudy.focus.text"/>
      <short value="Plain text representation of the concept"/>
      <definition
                  value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/>
      <comment
               value="Very often the text is the same as a displayName of one of the codings."/>
      <requirements
                    value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="CodeableConcept.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="v2"/>
        <map value="C*E.9. But note many systems use C*E.2 for this"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value="./originalText[mediaType/code=&quot;text/plain&quot;]/data"/>
      </mapping>
      <mapping>
        <identity value="orim"/>
        <map
             value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/>
      </mapping>
    </element>
    <element id="ResearchStudy.condition">
      <path value="ResearchStudy.condition"/>
      <short value="Condition being studied"/>
      <definition
                  value="The condition that is the focus of the study.  For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;, but the target condition code would be a Lupus SNOMED code."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.condition"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ConditionCode"/>
        </extension>
        <strength value="example"/>
        <description value="Identification of the condition or diagnosis."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/condition-code|4.3.0"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Conditions"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.what[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyCondition.code"/>
      </mapping>
    </element>
    <element id="ResearchStudy.contact">
      <path value="ResearchStudy.contact"/>
      <short value="Contact details for the study"/>
      <definition
                  value="Contact details to assist a user in learning more about or engaging with the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.contact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="ContactDetail"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Central Contact; Central Contact Backup; Overall Study Officials; Facility Contact &amp; Backup (if Study tied to only one location); Investigators"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="PointOfContact &gt; Project &gt; Research Project &gt; Study &gt; StudyProtocol &gt; StudyProtocolVersion"/>
      </mapping>
    </element>
    <element id="ResearchStudy.relatedArtifact">
      <path value="ResearchStudy.relatedArtifact"/>
      <short value="References and dependencies"/>
      <definition value="Citations, references and other related documents."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.relatedArtifact"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="RelatedArtifact"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Citations, Links, Available Study Data/Documents"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocument, StudyProtocolDocumentVersion"/>
      </mapping>
    </element>
    <element id="ResearchStudy.keyword">
      <path value="ResearchStudy.keyword"/>
      <short value="Used to search for the study"/>
      <definition
                  value="Key terms to aid in searching for or filtering the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.keyword"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyKeyword"/>
        </extension>
        <strength value="example"/>
        <description
                     value="Words associated with the study that may be useful in discovery."/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Keywords"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="DocumentVersion.keywordCode; DocumentVersion.keywordText"/>
      </mapping>
    </element>
    <element id="ResearchStudy.location">
      <path value="ResearchStudy.location"/>
      <short value="Geographic region(s) for study"/>
      <definition
                  value="Indicates a country, state or other region where the study is taking place."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.location"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="Jurisdiction"/>
        </extension>
        <strength value="extensible"/>
        <description
                     value="Countries and regions within which this artifact is targeted for use."/>
        <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction|4.3.0"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolVersion.participatingLocationCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.description">
      <path value="ResearchStudy.description"/>
      <short value="What this is study doing"/>
      <definition
                  value="A full description of how the study is being conducted."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.description"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Detailed Description"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyProtocolDocumentVersion.publicDescription"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment">
      <path value="ResearchStudy.enrollment"/>
      <short value="Inclusion &amp; exclusion criteria"/>
      <definition
                  value="Reference to a Group that defines the criteria for and quantity of subjects participating in the study.  E.g. &quot; 200 female Europeans between the ages of 20 and 45 with early onset diabetes&quot;."/>
      <comment
               value="The Group referenced should not generally enumerate specific subjects.  Subjects will be linked to the study using the ResearchSubject resource."/>
      <alias value="patient"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.enrollment"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Group|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map
             value="Enrollment; Number of Groups/Cohorts (= number of &quot;enrollment&quot; instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="InterventionalStudyProtocol.interventionGroupQuantity"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".participation[typeCode=SBJ].role"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.subject"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment.id">
      <path value="ResearchStudy.enrollment.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment.extension">
      <path value="ResearchStudy.enrollment.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.enrollment.extension:eligibility">
      <path value="ResearchStudy.enrollment.extension"/>
      <sliceName value="eligibility"/>
      <short value="R5: Inclusion and exclusion criteria additional types"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.eligibility` additional types from child elements (display, identifier, reference, type)"/>
      <comment
               value="Element `ResearchStudy.recruitment.eligibility` is mapped to FHIR R4B element `ResearchStudy.enrollment` as `RelatedTo`.
The mappings for `ResearchStudy.recruitment.eligibility` do not cover the following types based on type expansion: display, identifier, reference, type.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.recruitment.eligibility` with unmapped reference targets: EvidenceVariable."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.enrollment.reference">
      <path value="ResearchStudy.enrollment.reference"/>
      <short value="Literal reference, Relative, internal or absolute URL"/>
      <definition
                  value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources."/>
      <comment
               value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries.   Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure &quot;/[type]/[id]&quot; then it should be assumed that the reference is to a FHIR RESTful server."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.reference"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ref-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment.type">
      <path value="ResearchStudy.enrollment.type"/>
      <short value="Type the reference refers to (e.g. &quot;Patient&quot;)"/>
      <definition
                  value="The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. &quot;Patient&quot; is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources)."/>
      <comment
               value="This element is used to indicate the type of  the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/build/StructureDefinition/binding-definition">
          <valueString
                       value="Aa resource (or, for logical models, the URI of the logical model)."/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="FHIRResourceTypeExt"/>
        </extension>
        <strength value="extensible"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/resource-types|4.3.0"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment.identifier">
      <path value="ResearchStudy.enrollment.identifier"/>
      <short value="Logical reference, when literal reference is not known"/>
      <definition
                  value="An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference."/>
      <comment
               value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. 

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference.  For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport).  One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.identifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.enrollment.display">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ResearchStudy.enrollment.display"/>
      <short value="Text alternative for the resource"/>
      <definition
                  value="Plain text narrative that identifies the resource in addition to the resource reference."/>
      <comment
               value="This is generally not the same as the Resource.text of the referenced resource.  The purpose is to identify what's being referenced, not to fully describe it."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.display"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.period">
      <path value="ResearchStudy.period"/>
      <short value="When the study began and ended"/>
      <definition
                  value="Identifies the start date and the expected (or actual, depending on status) end date for the study."/>
      <alias value="timing"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.period"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Period"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Study Start Date (start); Study Completion Date (end)"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.done[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".effectiveTime"/>
      </mapping>
    </element>
    <element id="ResearchStudy.sponsor">
      <path value="ResearchStudy.sponsor"/>
      <short
             value="Organization that initiates and is legally responsible for the study"/>
      <definition
                  value="An organization that initiates the investigation and is legally responsible for the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.sponsor"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Organization|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Sponsor"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.actor"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="RegulatoryApplicationSponsor; StudyLegalSponsor; StudyProtocolVersion.responsiblePartyCode"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".participation[typeCode=PRF].role[scoper.determinerCode=INSTANCE]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.principalInvestigator">
      <path value="ResearchStudy.principalInvestigator"/>
      <short value="Researcher who oversees multiple aspects of the study"/>
      <definition
                  value="A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.principalInvestigator"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Practitioner|4.3.0"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/PractitionerRole|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Principal Investigator"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.actor"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyInvestigator"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site">
      <path value="ResearchStudy.site"/>
      <short value="Facility where study activities are conducted"/>
      <definition
                  value="A facility in which study activities are conducted."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.site"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Reference"/>
        <targetProfile
                       value="http://hl7.org/fhir/StructureDefinition/Location|4.3.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Facility"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.where[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="PlannedStudySite; StudySite"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site.id">
      <path value="ResearchStudy.site.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site.extension">
      <path value="ResearchStudy.site.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <description value="Extensions are always sliced by (at least) url"/>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.site.extension:site">
      <path value="ResearchStudy.site.extension"/>
      <sliceName value="site"/>
      <short value="R5: site"/>
      <definition value="R5: `ResearchStudy.site`"/>
      <comment
               value="Element `ResearchStudy.site` is mapped to FHIR R4B element `ResearchStudy.site` as `SourceIsBroaderThanTarget`.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.site` with unmapped reference targets: Organization, ResearchStudy."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.site.reference">
      <path value="ResearchStudy.site.reference"/>
      <short value="Literal reference, Relative, internal or absolute URL"/>
      <definition
                  value="A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources."/>
      <comment
               value="Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries.   Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure &quot;/[type]/[id]&quot; then it should be assumed that the reference is to a FHIR RESTful server."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.reference"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <condition value="ref-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site.type">
      <path value="ResearchStudy.site.type"/>
      <short value="Type the reference refers to (e.g. &quot;Patient&quot;)"/>
      <definition
                  value="The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. &quot;Patient&quot; is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources)."/>
      <comment
               value="This element is used to indicate the type of  the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="uri"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/build/StructureDefinition/binding-definition">
          <valueString
                       value="Aa resource (or, for logical models, the URI of the logical model)."/>
        </extension>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="FHIRResourceTypeExt"/>
        </extension>
        <strength value="extensible"/>
        <valueSet value="http://hl7.org/fhir/ValueSet/resource-types|4.3.0"/>
      </binding>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site.identifier">
      <path value="ResearchStudy.site.identifier"/>
      <short value="Logical reference, when literal reference is not known"/>
      <definition
                  value="An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference."/>
      <comment
               value="When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. 

When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference.  For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport).  One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.identifier"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </mapping>
    </element>
    <element id="ResearchStudy.site.display">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable">
        <valueBoolean value="true"/>
      </extension>
      <path value="ResearchStudy.site.display"/>
      <short value="Text alternative for the resource"/>
      <definition
                  value="Plain text narrative that identifies the resource in addition to the resource reference."/>
      <comment
               value="This is generally not the same as the Resource.text of the referenced resource.  The purpose is to identify what's being referenced, not to fully describe it."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Reference.display"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.reasonStopped">
      <path value="ResearchStudy.reasonStopped"/>
      <short
             value="accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design"/>
      <definition
                  value="A description and/or code explaining the premature termination of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.reasonStopped"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="true"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyReasonStopped"/>
        </extension>
        <strength value="example"/>
        <description value="Codes for why the study ended prematurely."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-reason-stopped|4.3.0"/>
      </binding>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Why Study Stopped"/>
      </mapping>
      <mapping>
        <identity value="w5"/>
        <map value="FiveWs.why[x]"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyOverallStatus.studyStoppedReasonCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.note">
      <path value="ResearchStudy.note"/>
      <short value="Comments made about the study"/>
      <definition
                  value="Comments made about the study by the performer, subject or other participants."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.note"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Annotation"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="No BRIDG mapping"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map
             value=".inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm">
      <path value="ResearchStudy.arm"/>
      <short value="Defined path through the study for a subject"/>
      <definition
                  value="Describes an expected sequence of events for one of the participants of a study.  E.g. Exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.arm"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arms"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.id">
      <path value="ResearchStudy.arm.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.extension">
      <path value="ResearchStudy.arm.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.arm.extension:linkId">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="linkId"/>
      <short
             value="R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.linkId` (new:id)"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.linkId` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.linkId` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.arm.extension:intendedExposure">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="intendedExposure"/>
      <short
             value="R5: Interventions or exposures in this comparisonGroup or cohort (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.intendedExposure` (new:Reference(EvidenceVariable))"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.intendedExposure` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.intendedExposure` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.arm.extension:observedGroup">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="observedGroup"/>
      <short
             value="R5: Group of participants who were enrolled in study comparisonGroup (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.observedGroup` (new:Reference(Group))"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.observedGroup` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.observedGroup` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.arm.modifierExtension">
      <path value="ResearchStudy.arm.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.name">
      <path value="ResearchStudy.arm.name"/>
      <short value="Label for study arm"/>
      <definition
                  value="Unique, human-readable label for this arm of the study."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.name"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Label"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.name"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.type">
      <path value="ResearchStudy.arm.type"/>
      <short value="Categorization of study arm"/>
      <definition
                  value="Categorization of study arm, e.g. experimental, active comparator, placebo comparater."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Type"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.typeCode"/>
      </mapping>
    </element>
    <element id="ResearchStudy.arm.description">
      <path value="ResearchStudy.arm.description"/>
      <short value="Short explanation of study path"/>
      <definition
                  value="A succinct description of the path through the study that would be followed by a subject adhering to this arm."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.arm.description"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="clinicaltrials-gov"/>
        <map value="Arm Description"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="Arm.description"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective">
      <path value="ResearchStudy.objective"/>
      <short value="A goal for the study"/>
      <definition
                  value="A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="ResearchStudy.objective"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyObjective"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.id">
      <path value="ResearchStudy.objective.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="string"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.extension">
      <path value="ResearchStudy.objective.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.objective.extension:description">
      <path value="ResearchStudy.objective.extension"/>
      <sliceName value="description"/>
      <short value="R5: Description of the objective (new)"/>
      <definition
                  value="R5: `ResearchStudy.objective.description` (new:markdown)"/>
      <comment
               value="Element `ResearchStudy.objective.description` has a context of ResearchStudy.objective based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.objective.description` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description|0.1.0"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
    </element>
    <element id="ResearchStudy.objective.modifierExtension">
      <path value="ResearchStudy.objective.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Extension|4.3.0"/>
      </constraint>
      <isModifier value="true"/>
      <isModifierReason
                        value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/>
      <isSummary value="true"/>
      <mapping>
        <identity value="rim"/>
        <map value="N/A"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.name">
      <path value="ResearchStudy.objective.name"/>
      <short value="Label for the objective"/>
      <definition
                  value="Unique, human-readable label for this objective of the study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.objective.name"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map
             value="No BRIDG mapping (BRIDG has a description, but not a name)"/>
      </mapping>
    </element>
    <element id="ResearchStudy.objective.type">
      <path value="ResearchStudy.objective.type"/>
      <short value="primary | secondary | exploratory"/>
      <definition value="The kind of study objective."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="ResearchStudy.objective.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="CodeableConcept"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source
                value="http://hl7.org/fhir/StructureDefinition/Element|4.3.0"/>
      </constraint>
      <mustSupport value="false"/>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <binding>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
          <valueString value="ResearchStudyObjectiveType"/>
        </extension>
        <strength value="preferred"/>
        <description value="Codes for the kind of study objective."/>
        <valueSet
                  value="http://hl7.org/fhir/ValueSet/research-study-objective-type|4.3.0"/>
      </binding>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudyObjective.typeCode"/>
      </mapping>
    </element>
  </snapshot>
  <differential>
    <element id="ResearchStudy">
      <path value="ResearchStudy"/>
    </element>
    <element id="ResearchStudy.extension">
      <path value="ResearchStudy.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.extension:url">
      <path value="ResearchStudy.extension"/>
      <sliceName value="url"/>
      <short value="R5: Canonical identifier for this study resource (new)"/>
      <definition value="R5: `ResearchStudy.url` (new:uri)"/>
      <comment
               value="Element `ResearchStudy.url` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.url` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.url|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:version">
      <path value="ResearchStudy.extension"/>
      <sliceName value="version"/>
      <short value="R5: The business version for the study record (new)"/>
      <definition value="R5: `ResearchStudy.version` (new:string)"/>
      <comment
               value="Element `ResearchStudy.version` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.version` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.version|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:name">
      <path value="ResearchStudy.extension"/>
      <sliceName value="name"/>
      <short value="R5: Name for this study (computer friendly) (new)"/>
      <definition value="R5: `ResearchStudy.name` (new:string)"/>
      <comment
               value="Element `ResearchStudy.name` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.name` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.name|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:label">
      <path value="ResearchStudy.extension"/>
      <sliceName value="label"/>
      <short value="R5: Additional names for the study (new)"/>
      <definition value="R5: `ResearchStudy.label` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.label` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.label` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.label|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:date">
      <path value="ResearchStudy.extension"/>
      <sliceName value="date"/>
      <short value="R5: Date the resource last changed (new)"/>
      <definition value="R5: `ResearchStudy.date` (new:dateTime)"/>
      <comment
               value="Element `ResearchStudy.date` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.date` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.date|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:studyDesign">
      <path value="ResearchStudy.extension"/>
      <sliceName value="studyDesign"/>
      <short
             value="R5: Classifications of the study design characteristics (new)"/>
      <definition
                  value="R5: `ResearchStudy.studyDesign` (new:CodeableConcept)"/>
      <comment
               value="Element `ResearchStudy.studyDesign` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.studyDesign` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.studyDesign|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:descriptionSummary">
      <path value="ResearchStudy.extension"/>
      <sliceName value="descriptionSummary"/>
      <short value="R5: Brief text explaining the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.descriptionSummary` (new:markdown)"/>
      <comment
               value="Element `ResearchStudy.descriptionSummary` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.descriptionSummary` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.descriptionSummary|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:classifier">
      <path value="ResearchStudy.extension"/>
      <sliceName value="classifier"/>
      <short value="R5: Classification for the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.classifier` (new:CodeableConcept)"/>
      <comment
               value="Element `ResearchStudy.classifier` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.classifier` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.classifier|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:associatedParty">
      <path value="ResearchStudy.extension"/>
      <sliceName value="associatedParty"/>
      <short value="R5: Sponsors, collaborators, and other parties (new)"/>
      <definition
                  value="R5: `ResearchStudy.associatedParty` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.associatedParty` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.associatedParty` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).
For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.associatedParty|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:progressStatus">
      <path value="ResearchStudy.extension"/>
      <sliceName value="progressStatus"/>
      <short value="R5: Status of study with time for that status (new)"/>
      <definition
                  value="R5: `ResearchStudy.progressStatus` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.progressStatus` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.progressStatus` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.progressStatus|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:targetNumber">
      <path value="ResearchStudy.extension"/>
      <sliceName value="targetNumber"/>
      <short
             value="R5: Estimated total number of participants to be enrolled (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.targetNumber` (new:unsignedInt)"/>
      <comment
               value="Element `ResearchStudy.recruitment.targetNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.targetNumber` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.targetNumber|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:actualNumber">
      <path value="ResearchStudy.extension"/>
      <sliceName value="actualNumber"/>
      <short
             value="R5: Actual total number of participants enrolled in study (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.actualNumber` (new:unsignedInt)"/>
      <comment
               value="Element `ResearchStudy.recruitment.actualNumber` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.actualNumber` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualNumber|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:actualGroup">
      <path value="ResearchStudy.extension"/>
      <sliceName value="actualGroup"/>
      <short
             value="R5: Group of participants who were enrolled in study (new)"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.actualGroup` (new:Reference(Group))"/>
      <comment
               value="Element `ResearchStudy.recruitment.actualGroup` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.recruitment.actualGroup` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.recruitment.actualGroup|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:outcomeMeasure">
      <path value="ResearchStudy.extension"/>
      <sliceName value="outcomeMeasure"/>
      <short value="R5: A variable measured during the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.outcomeMeasure` (new:BackboneElement)"/>
      <comment
               value="Element `ResearchStudy.outcomeMeasure` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.outcomeMeasure` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element).
A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.outcomeMeasure|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.extension:result">
      <path value="ResearchStudy.extension"/>
      <sliceName value="result"/>
      <short value="R5: Link to results generated during the study (new)"/>
      <definition
                  value="R5: `ResearchStudy.result` (new:Reference(EvidenceReport,Citation,DiagnosticReport))"/>
      <comment
               value="Element `ResearchStudy.result` has a context of ResearchStudy based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.result` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.result|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.status.extension">
      <path value="ResearchStudy.status.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.status.extension:status">
      <path value="ResearchStudy.status.extension"/>
      <sliceName value="status"/>
      <short value="R5: draft | active | retired | unknown additional codes"/>
      <definition value="R5: `ResearchStudy.status` additional codes"/>
      <comment
               value="Element `ResearchStudy.status` is mapped to FHIR R4B element `ResearchStudy.status` as `RelatedTo`.
The mappings for `ResearchStudy.status` do not allow expression of the necessary codes, per the bindings on the source and target.
The target context `ResearchStudy.status` is a modifier element, so this extension does not need to be defined as a modifier."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.status|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.focus.extension">
      <path value="ResearchStudy.focus.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.focus.extension:focus">
      <path value="ResearchStudy.focus.extension"/>
      <sliceName value="focus"/>
      <short value="R5: focus additional types"/>
      <definition
                  value="R5: `ResearchStudy.focus` additional types (CodeableReference(http://hl7.org/fhir/StructureDefinition/Medication), CodeableReference(http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/SubstanceDefinition), CodeableReference(http://hl7.org/fhir/StructureDefinition/EvidenceVariable))"/>
      <comment
               value="Element `ResearchStudy.focus` is mapped to FHIR R4B element `ResearchStudy.focus` as `SourceIsBroaderThanTarget`.
The mappings for `ResearchStudy.focus` do not cover the following types: CodeableReference."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.focus|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.enrollment.extension">
      <path value="ResearchStudy.enrollment.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.enrollment.extension:eligibility">
      <path value="ResearchStudy.enrollment.extension"/>
      <sliceName value="eligibility"/>
      <short value="R5: Inclusion and exclusion criteria additional types"/>
      <definition
                  value="R5: `ResearchStudy.recruitment.eligibility` additional types from child elements (display, identifier, reference, type)"/>
      <comment
               value="Element `ResearchStudy.recruitment.eligibility` is mapped to FHIR R4B element `ResearchStudy.enrollment` as `RelatedTo`.
The mappings for `ResearchStudy.recruitment.eligibility` do not cover the following types based on type expansion: display, identifier, reference, type.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.recruitment.eligibility` with unmapped reference targets: EvidenceVariable."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"/>
      </type>
    </element>
    <element id="ResearchStudy.site.extension">
      <path value="ResearchStudy.site.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.site.extension:site">
      <path value="ResearchStudy.site.extension"/>
      <sliceName value="site"/>
      <short value="R5: site"/>
      <definition value="R5: `ResearchStudy.site`"/>
      <comment
               value="Element `ResearchStudy.site` is mapped to FHIR R4B element `ResearchStudy.site` as `SourceIsBroaderThanTarget`.
The standard extension `alternate-reference` has been mapped as the representation of FHIR R5 element `ResearchStudy.site` with unmapped reference targets: Organization, ResearchStudy."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/StructureDefinition/alternate-reference|5.2.0"/>
      </type>
    </element>
    <element id="ResearchStudy.arm.extension">
      <path value="ResearchStudy.arm.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.arm.extension:linkId">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="linkId"/>
      <short
             value="R5: Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.linkId` (new:id)"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.linkId` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.linkId` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.linkId|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.arm.extension:intendedExposure">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="intendedExposure"/>
      <short
             value="R5: Interventions or exposures in this comparisonGroup or cohort (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.intendedExposure` (new:Reference(EvidenceVariable))"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.intendedExposure` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.intendedExposure` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.intendedExposure|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.arm.extension:observedGroup">
      <path value="ResearchStudy.arm.extension"/>
      <sliceName value="observedGroup"/>
      <short
             value="R5: Group of participants who were enrolled in study comparisonGroup (new)"/>
      <definition
                  value="R5: `ResearchStudy.comparisonGroup.observedGroup` (new:Reference(Group))"/>
      <comment
               value="Element `ResearchStudy.comparisonGroup.observedGroup` has a context of ResearchStudy.arm based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.comparisonGroup.observedGroup` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.comparisonGroup.observedGroup|0.1.0"/>
      </type>
    </element>
    <element id="ResearchStudy.objective.extension">
      <path value="ResearchStudy.objective.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <min value="0"/>
      <max value="*"/>
    </element>
    <element id="ResearchStudy.objective.extension:description">
      <path value="ResearchStudy.objective.extension"/>
      <sliceName value="description"/>
      <short value="R5: Description of the objective (new)"/>
      <definition
                  value="R5: `ResearchStudy.objective.description` (new:markdown)"/>
      <comment
               value="Element `ResearchStudy.objective.description` has a context of ResearchStudy.objective based on following the parent source element upwards and mapping to `ResearchStudy`.
Element `ResearchStudy.objective.description` has no mapping targets in FHIR R4B. Typically, this is because the element has been added (is a new element)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="http://hl7.org/fhir/5.0/StructureDefinition/extension-ResearchStudy.objective.description|0.1.0"/>
      </type>
    </element>
  </differential>
</StructureDefinition>