Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## Resource Profile: M11 Research Study Profile - XML Profile

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

XML representation of the m11-research-study-profile resource profile.

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    <StructureDefinition xmlns="http://hl7.org/fhir">
      <id value="m11-research-study-profile"/>
      <language value="en"/>
      <text>
        <status value="extensions"/>
        <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: StructureDefinition m11-research-study-profile</b></p><a name="m11-research-study-profile"> </a><a name="hcm11-research-study-profile"> </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, " 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-m11-research-study-profile-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"><a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;; padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://build.fhir.org/conformance-rules.html#constraints" title="This element has or is affected by constraints ( identifier-required )">C</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">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/R5/researchstudy.html">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"><span style="opacity: 0.5">Investigation to increase healthcare-related patient-independent knowledge</span><br class="constraint"/><span title="null" class="constraint">Constraints: </span><span style="font-weight:bold" title="The identifier MUST be populated with at least a Sponsor identifier" class="constraint">identifier-required</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-m11-research-study-profile-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">1..<span style="opacity: 0.5">*</span></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/6.0.0-ballot3/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</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-m11-research-study-profile-definitions.html#ResearchStudy.extension:narrative" title="Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements">extension:narrative</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"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : 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/R5/references.html">Reference</a>(<a href="StructureDefinition-m11-research-study-narratives.html">Research Study Narratives</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">Narrative Elements</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-narrative-elements.html">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements</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-m11-research-study-profile-definitions.html#ResearchStudy.extension:amendment" title="Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment">extension:amendment</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"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : 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">(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"><span style="opacity: 0.5">Amendment to a protocol - from EBM</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-m11-protocol-amendment.html">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment</a></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-m11-research-study-profile-definitions.html#ResearchStudy.extension:confidentialityStatement" title="Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement">extension:confidentialityStatement</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/R5/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"><span style="opacity: 0.5">Sponsor Confidentiality Statement, if applicable.</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-m11-confidentiality-statement.html">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement</a></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-m11-research-study-profile-definitions.html#ResearchStudy.extension:approval" title="Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval">extension:approval</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"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : 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">(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"><span style="opacity: 0.5">Sign-off details</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-m11-approval.html">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval</a></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-m11-research-study-profile-definitions.html#ResearchStudy.extension:m11-research-study" title="Extension URL = http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study">extension:m11-research-study</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"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : 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"><span style="opacity: 0.5">Additional concepts for M11</span><br/><span style="font-weight:bold">URL: </span><a href="StructureDefinition-m11-research-study.html">http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study</a></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-m11-research-study-profile-definitions.html#ResearchStudy.identifier">identifier</a><a name="ResearchStudy.identifier"> </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="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</span></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/R5/datatypes.html#Identifier">Identifier</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">Business Identifier for study</span></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_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.identifier.type">type</a><a name="ResearchStudy.identifier.type"> </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="padding-left: 3px; padding-right: 3px; color: black; null" title="This element is a modifier element">?!</span><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : 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/R5/datatypes.html#CodeableConcept">CodeableConcept</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">Description of identifier</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-udp-identifier-type-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs" class="binding">UDP Identifier Type Value Set</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible</a><span title="null" class="binding">)</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_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.identifier.type.coding">coding</a><a name="ResearchStudy.identifier.type.coding"> </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_bck10000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.identifier.type.coding.code">code</a><a name="ResearchStudy.identifier.type.coding.code"> </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">1..<span style="opacity: 0.5">1</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 style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#code">code</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">Symbol in syntax defined by the system</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_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.title">title</a><a name="ResearchStudy.title"> </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="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; 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">1</span></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/R5/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"><span style="opacity: 0.5">Human readable name of the study</span></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-m11-research-study-profile-definitions.html#ResearchStudy.label">label</a><a name="ResearchStudy.label"> </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_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.label.type">type</a><a name="ResearchStudy.label.type"> </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"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></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/R5/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"><span style="opacity: 0.5">primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-udp-study-title-type-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs" class="binding">UDP Study Title Type Value Set</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible</a><span title="null" class="binding">)</span></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-m11-research-study-profile-definitions.html#ResearchStudy.relatesTo">relatesTo</a><a name="ResearchStudy.relatesTo"> </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_bck100.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.relatesTo.type">type</a><a name="ResearchStudy.relatesTo.type"> </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"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : 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/R5/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"><span style="opacity: 0.5">documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes</span></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_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.phase">phase</a><a name="ResearchStudy.phase"> </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="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : 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">1</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 style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/datatypes.html#CodeableConcept">CodeableConcept</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">Classifier used for clinical trials</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-m11-phase-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs" class="binding">ICH M11 Trial Phase Value Set Terminology</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/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></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_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-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: #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"><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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R5/references.html">CodeableReference</a>(<a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/medication.html">Medication</a> | <a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/medicinalproductdefinition.html">MedicinalProductDefinition</a> | <a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/substancedefinition.html">SubstanceDefinition</a> | <a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/devicedefinition.html">DeviceDefinition</a> | <a style="opacity: 0.5; opacity: 0.5" href="http://hl7.org/fhir/R5/plandefinition.html">PlanDefinition</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">Drugs, devices, etc. under study</span></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-m11-research-study-profile-definitions.html#ResearchStudy.associatedParty">associatedParty</a><a name="ResearchStudy.associatedParty"> </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_bck010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.associatedParty.role">role</a><a name="ResearchStudy.associatedParty.role"> </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"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : 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/R5/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"><span style="opacity: 0.5">sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb</span><br class="binding"/><span style="font-weight:bold" title="null" class="binding">Binding: </span><a href="ValueSet-udp-party-role-type-vs.html" title="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs" class="binding">UDP Party Role Type Value Set</a><span title="null" class="binding"> (</span><a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead." class="binding">extensible</a><span title="null" class="binding">)</span></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_bck001.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_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-m11-research-study-profile-definitions.html#ResearchStudy.associatedParty.party">party</a><a name="ResearchStudy.associatedParty.party"> </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_bck0000.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.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-m11-research-study-profile-definitions.html#ResearchStudy.associatedParty.party.reference">reference</a><a name="ResearchStudy.associatedParty.party.reference"> </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="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : var(--ig-left,left); background-color: #F7F7F7; 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">1</span></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/R5/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"><span style="opacity: 0.5">Literal reference, Relative, internal or absolute URL</span></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, " alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
        <valueInteger value="2"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
        <valueCode value="brr"/>
      </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/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"/>
          </extension>
        </valueCode>
      </extension>
      <url
           value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"/>
      <version value="1.0.0-ballot2"/>
      <name value="M11_ResearchStudyProfile"/>
      <title value="M11 Research Study Profile"/>
      <status value="active"/>
      <date value="2026-04-09T17:15:23+10:00"/>
      <publisher value="HL7 International / Biomedical Research and Regulation"/>
      <contact>
        <name value="HL7 International / Biomedical Research and Regulation"/>
        <telecom>
          <system value="url"/>
          <value value="http://www.hl7.org/Special/committees/rcrim"/>
        </telecom>
        <telecom>
          <system value="email"/>
          <value value="UDP@HL7Vulcan.org"/>
        </telecom>
      </contact>
      <description
                   value="Constraint of ResearchStudy to M11 Guidance
    An instance of this profile represents a single version of the protocol definition. Previous amendments are represented
    by further instances of ResearchStudy linked through the relatesTo attribute. "/>
      <jurisdiction>
        <coding>
          <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
          <code value="001"/>
          <display value="World"/>
        </coding>
      </jurisdiction>
      <copyright
                 value="Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP.
    The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license.

    CDISC publishes semantics for the ICH M11 protocol data elements and valid
    value sets. This terminology set is published and stored in the NCI Thesaurus
    Subset C217023 - ICH M11 Terminology
    (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023)

    The NCI Thesaurus is released under the CC BY 4.0 license

    CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license

    For more licensing information and links see: [licenses.html](licenses.html)"/>
      <fhirVersion value="6.0.0-ballot3"/>
      <mapping>
        <identity value="w5"/>
        <uri value="http://hl7.org/fhir/fivews"/>
        <name value="FiveWs Pattern Mapping"/>
      </mapping>
      <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="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"/>
      <derivation value="constraint"/>
      <snapshot>
        <extension
                   url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version">
          <valueString value="6.0.0-ballot3"/>
        </extension>
        <element id="ResearchStudy">
          <path value="ResearchStudy"/>
          <short
                 value="Investigation to increase healthcare-related patient-independent knowledge"/>
          <definition
                      value="A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future."/>
          <comment
                   value="The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people."/>
          <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()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </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.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </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()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </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()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </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()"/>
            <source
                    value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
          </constraint>
          <constraint>
            <key value="identifier-required"/>
            <severity value="error"/>
            <human
                   value="The identifier MUST be populated with at least a Sponsor identifier"/>
            <expression value="identifier.exists()"/>
            <source
                    value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map
                 value="Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]"/>
          </mapping>
          <mapping>
            <identity value="w5"/>
            <map value="clinical.diagnostics"/>
          </mapping>
          <mapping>
            <identity value="BRIDG5.1"/>
            <map
                 value="ObservationalStudyProtocolVersion; Study;
    StudyProtocolVersion"/>
          </mapping>
          <mapping>
            <identity value="v2"/>
            <map value="OBX"/>
          </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="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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 its 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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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 its 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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="Language"/>
            </extension>
            <strength value="required"/>
            <description value="IETF language tag for a human language"/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/all-languages|6.0.0-ballot3"/>
            <additional>
              <purpose value="starter"/>
              <valueSet
                        value="http://hl7.org/fhir/ValueSet/languages|6.0.0-ballot3"/>
            </additional>
          </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 a 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>
          <condition value="dom-6"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <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, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/>
          <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. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional)."/>
          <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>
          <condition value="dom-2"/>
          <condition value="dom-4"/>
          <condition value="dom-3"/>
          <condition value="dom-5"/>
          <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="1"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.extension:narrative">
          <path value="ResearchStudy.extension"/>
          <sliceName value="narrative"/>
          <short value="Narrative Elements"/>
          <definition value="Narrative content for the 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/uv/clinical-study-protocol/StructureDefinition/narrative-elements"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.extension:amendment">
          <path value="ResearchStudy.extension"/>
          <sliceName value="amendment"/>
          <short value="Amendment to a protocol - from EBM"/>
          <definition value="Representation of amendments to a study protocol."/>
          <comment
                   value="The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases."/>
          <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/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.extension:confidentialityStatement">
          <path value="ResearchStudy.extension"/>
          <sliceName value="confidentialityStatement"/>
          <short value="Sponsor Confidentiality Statement, if applicable."/>
          <definition value="Sponsor Confidentiality Statement, if applicable."/>
          <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/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.extension:approval">
          <path value="ResearchStudy.extension"/>
          <sliceName value="approval"/>
          <short value="Sign-off details"/>
          <definition value="Signature and date for approval."/>
          <comment
                   value="This may need transferring into the StudyDesign profile eventually."/>
          <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/uv/clinical-study-protocol/StructureDefinition/m11-approval"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <constraint>
            <key value="date-required"/>
            <severity value="warning"/>
            <human
                   value="At least one of approvalDate or signatureUrl SHOULD be populated."/>
            <expression
                        value="extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()"/>
            <source
                    value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.extension:m11-research-study">
          <path value="ResearchStudy.extension"/>
          <sliceName value="m11-research-study"/>
          <short value="Additional concepts for M11"/>
          <definition value="Signature and date for approval."/>
          <comment
                   value="Additional concepts required by M11 that have no other obvious home."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="DomainResource.extension"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <constraint>
            <key value="ext-1"/>
            <severity value="error"/>
            <human value="Must have either extensions or value[x], not both"/>
            <expression value="extension.exists() != value.exists()"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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="true"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="ResearchStudy.url">
          <path value="ResearchStudy.url"/>
          <short value="Canonical identifier for this study resource"/>
          <definition
                      value="Canonical identifier for this study resource, represented as a globally unique URI."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.url"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </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="1"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <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.identifier.id">
          <path value="ResearchStudy.identifier.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.extension">
          <path value="ResearchStudy.identifier.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.use">
          <path value="ResearchStudy.identifier.use"/>
          <short value="usual | official | temp | secondary | old (If known)"/>
          <definition value="The purpose of this identifier."/>
          <comment
                   value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
          <requirements
                        value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.use"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="true"/>
          <isModifierReason
                            value="This is labeled as &quot;Is Modifier&quot; because applications should not mistake a temporary id for a permanent one."/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="IdentifierUse"/>
            </extension>
            <strength value="required"/>
            <description
                         value="Identifies the purpose for this identifier, if known ."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/identifier-use|6.0.0-ballot3"/>
          </binding>
          <mapping>
            <identity value="v2"/>
            <map value="N/A"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.code or implied by context"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type">
          <path value="ResearchStudy.identifier.type"/>
          <short value="Description of identifier"/>
          <definition
                      value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
          <comment
                   value="This element deals only with general categories of identifiers.  It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage.   Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
          <requirements
                        value="Allows users to make use of identifiers when the identifier system is not known."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Identifier.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs"/>
          </binding>
          <mapping>
            <identity value="v2"/>
            <map value="CX.5"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.code or implied by context"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.id">
          <path value="ResearchStudy.identifier.type.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.extension">
          <path value="ResearchStudy.identifier.type.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding">
          <path value="ResearchStudy.identifier.type.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <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.identifier.type.coding.id">
          <path value="ResearchStudy.identifier.type.coding.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.extension">
          <path value="ResearchStudy.identifier.type.coding.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.system">
          <path value="ResearchStudy.identifier.type.coding.system"/>
          <short value="Identity of the terminology system"/>
          <definition
                      value="The identification of the code system that defines the meaning of the symbol in the code."/>
          <comment
                   value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...).  OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously."/>
          <requirements
                        value="Need to be unambiguous about the source of the definition of the symbol."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.system"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.3"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystem"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.version">
          <path value="ResearchStudy.identifier.type.coding.version"/>
          <short value="Version of the system - if relevant"/>
          <definition
                      value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/>
          <comment
                   value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.version"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.7"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./codeSystemVersion"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.code">
          <path value="ResearchStudy.identifier.type.coding.code"/>
          <short value="Symbol in syntax defined by the system"/>
          <definition
                      value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/>
          <requirements
                        value="Need to refer to a particular code in the system."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="Coding.code"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="code"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="./code"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.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.identifier.type.coding.display"/>
          <short value="Representation defined by the system"/>
          <definition
                      value="A representation of the meaning of the code in the system, following the rules of the system."/>
          <requirements
                        value="Need to be able to carry a human-readable meaning of the code for readers that do not know  the system."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.display"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <condition value="cod-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="C*E.2 - but note this is not well followed"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CV.displayName"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.coding.userSelected">
          <path value="ResearchStudy.identifier.type.coding.userSelected"/>
          <short value="If this coding was chosen directly by the user"/>
          <definition
                      value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/>
          <comment
                   value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/>
          <requirements
                        value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Coding.userSelected"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="Sometimes implied by being first"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="CD.codingRationale"/>
          </mapping>
          <mapping>
            <identity value="orim"/>
            <map
                 value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map;   fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [     fhir:source &quot;true&quot;;     fhir:target dt:CDCoding.codingRationale\#O   ]"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.type.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.identifier.type.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <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.identifier.system">
          <path value="ResearchStudy.identifier.system"/>
          <short value="The namespace for the identifier value"/>
          <definition
                      value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/>
          <comment
                   value="Identifier.system is always case sensitive. The FHIR specification, terminology.hl7.org and HL7 affiliates (for identifiers specific to their jurisdiction) define identifier systems that SHALL be used for certain types of identifiers.  Specific rules can be found [here](http://build.fhir.org/identifier-registry.html)."/>
          <requirements
                        value="There are many sets  of identifiers.  To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.system"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <example>
            <label value="General"/>
            <valueUri value="http://www.acme.com/identifiers/patient"/>
          </example>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.4 / EI-2-4"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="II.root or Role.id.root"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./IdentifierType"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.value">
          <path value="ResearchStudy.identifier.value"/>
          <short value="The value that is unique"/>
          <definition
                      value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
          <comment
                   value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986.  The value's primary purpose is computational mapping.  As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.)  A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.value"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="string"/>
          </type>
          <example>
            <label value="General"/>
            <valueString value="123456"/>
          </example>
          <condition value="ident-1"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.1 / EI.1"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./Value"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.period">
          <path value="ResearchStudy.identifier.period"/>
          <short value="Time period when id is/was valid for use"/>
          <definition
                      value="Time period during which identifier is/was valid for use."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.7 + CX.8"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map value="Role.effectiveTime or implied by context"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./StartDate and ./EndDate"/>
          </mapping>
        </element>
        <element id="ResearchStudy.identifier.assigner">
          <path value="ResearchStudy.identifier.assigner"/>
          <short value="Organization that issued id (may be just text)"/>
          <definition value="Organization that issued/manages the identifier."/>
          <comment
                   value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Identifier.assigner"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="v2"/>
            <map value="CX.4 / (CX.4,CX.9,CX.10)"/>
          </mapping>
          <mapping>
            <identity value="rim"/>
            <map
                 value="II.assigningAuthorityName but note that this is an improper use by the definition of the field.  Also Role.scoper"/>
          </mapping>
          <mapping>
            <identity value="servd"/>
            <map value="./IdentifierIssuingAuthority"/>
          </mapping>
        </element>
        <element id="ResearchStudy.version">
          <path value="ResearchStudy.version"/>
          <short value="The business version for the study record"/>
          <definition value="The business version for the study record."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.version"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.name">
          <path value="ResearchStudy.name"/>
          <short value="Name for this study (computer friendly)"/>
          <definition value="Name for this study (computer friendly)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.title">
          <path value="ResearchStudy.title"/>
          <short value="Human readable name of the study"/>
          <definition value="The human readable name of the research study."/>
          <comment
                   value="The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches."/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <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.label">
          <path value="ResearchStudy.label"/>
          <short value="Additional names for the study"/>
          <definition value="Additional names for the study."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.label"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.label.id">
          <path value="ResearchStudy.label.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.label.extension">
          <path value="ResearchStudy.label.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.label.modifierExtension">
          <path value="ResearchStudy.label.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.label.type">
          <path value="ResearchStudy.label.type"/>
          <short
                 value="primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid"/>
          <definition value="Kind of name."/>
          <comment value="The value set used here is defined by CDISC/DDF"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.label.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.label.value">
          <path value="ResearchStudy.label.value"/>
          <short value="The name"/>
          <definition value="The name."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.label.value"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </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|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <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>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-hierarchy">
              <valueBoolean value="true"/>
            </extension>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <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.citeAs">
          <path value="ResearchStudy.citeAs"/>
          <short value="How to cite this ResearchStudy"/>
          <definition
                      value="Display of the bibliographic citation of this ResearchStudy."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.citeAs"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.relatesTo">
          <path value="ResearchStudy.relatesTo"/>
          <short value="Relationships to other Resources"/>
          <definition
                      value="Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.relatesTo"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.relatesTo.id">
          <path value="ResearchStudy.relatesTo.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.relatesTo.extension">
          <path value="ResearchStudy.relatesTo.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.relatesTo.modifierExtension">
          <path value="ResearchStudy.relatesTo.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.relatesTo.type">
          <path value="ResearchStudy.relatesTo.type"/>
          <short
                 value="documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes"/>
          <definition value="The type of relationship to the related artifact."/>
          <comment
                   value="Set to a value of predecessor to indicate the target is the previous version of the protocol or to C218694
                                to indicate the target is the amendment details that have been incorporated"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.relatesTo.type"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ArtifactRelationshipType"/>
            </extension>
            <strength value="required"/>
            <description
                         value="The type of relationship to the related artifact."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/artifact-relationship-type|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.relatesTo.target[x]">
          <path value="ResearchStudy.relatesTo.target[x]"/>
          <short value="The artifact that is related to this ResearchStudy"/>
          <definition
                      value="The artifact that is related to this ResearchStudy Resource."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.relatesTo.target[x]"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="uri"/>
          </type>
          <type>
            <code value="Attachment"/>
          </type>
          <type>
            <code value="canonical"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Resource|6.0.0-ballot3"/>
          </type>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Resource|6.0.0-ballot3"/>
          </type>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.date">
          <path value="ResearchStudy.date"/>
          <short value="Date the resource last changed"/>
          <definition
                      value="The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.date"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="dateTime"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.status">
          <path value="ResearchStudy.status"/>
          <short value="draft | active | retired | unknown"/>
          <definition
                      value="The publication state of the resource (not 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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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="PublicationStatus"/>
            </extension>
            <strength value="required"/>
            <description
                         value="Codes that convey the current publication status of the research study resource."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/publication-status|6.0.0-ballot3"/>
          </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.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 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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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="preferred"/>
            <description value="Codes for the main intent of the study."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-prim-purp-type|6.0.0-ballot3"/>
          </binding>
          <mapping>
            <identity value="BRIDG5.1"/>
            <map value="StudyProtocolVersion.primaryPurposeTypeCode"/>
          </mapping>
        </element>
        <element id="ResearchStudy.phase">
          <path value="ResearchStudy.phase"/>
          <short value="Classifier used for clinical trials"/>
          <definition
                      value="The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
          <comment
                   value="M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding."/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs"/>
          </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.studyDesign">
          <path value="ResearchStudy.studyDesign"/>
          <short value="Classifications of the study design characteristics"/>
          <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.studyDesign"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="StudyDesign"/>
            </extension>
            <strength value="preferred"/>
            <description
                         value="This is a set of terms for study design characteristics."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/study-design|6.0.0-ballot3"/>
          </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."/>
          <comment
                   value="Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.focus"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="CodeableReference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Medication|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/SubstanceDefinition|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/PlanDefinition|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ResearchStudyFocusType"/>
            </extension>
            <strength value="example"/>
            <description value="Some example codes of research study focus"/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3"/>
          </binding>
        </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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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|6.0.0-ballot3"/>
          </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.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ResearchStudyFocusType"/>
            </extension>
            <strength value="example"/>
            <description value="Some example codes."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-focus-type|6.0.0-ballot3"/>
          </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.region">
          <path value="ResearchStudy.region"/>
          <short value="Geographic area for the study"/>
          <definition
                      value="A country, state or other area where the study is taking place rather than its precise geographic location or address."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.region"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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|6.0.0-ballot3"/>
          </binding>
          <mapping>
            <identity value="BRIDG5.1"/>
            <map value="StudyProtocolVersion.participatingLocationCode"/>
          </mapping>
        </element>
        <element id="ResearchStudy.descriptionSummary">
          <path value="ResearchStudy.descriptionSummary"/>
          <short value="Brief text explaining the study"/>
          <definition value="A brief text for explaining the study."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.descriptionSummary"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.description">
          <path value="ResearchStudy.description"/>
          <short value="Detailed narrative of the study"/>
          <definition
                      value="A detailed and human-readable narrative of the study. E.g., study abstract."/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.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|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/ResearchStudy|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <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.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.classifier">
          <path value="ResearchStudy.classifier"/>
          <short value="Classification for the study"/>
          <definition
                      value="Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.classifier"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ResearchStudyClassifiers"/>
            </extension>
            <strength value="example"/>
            <description value="desc."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-classifiers|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.associatedParty">
          <path value="ResearchStudy.associatedParty"/>
          <short value="Sponsors, collaborators, and other parties"/>
          <definition value="Sponsors, collaborators, and other parties."/>
          <comment
                   value="For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided."/>
          <requirements
                        value="While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.associatedParty"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.associatedParty.id">
          <path value="ResearchStudy.associatedParty.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.extension">
          <path value="ResearchStudy.associatedParty.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.modifierExtension">
          <path value="ResearchStudy.associatedParty.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.associatedParty.name">
          <path value="ResearchStudy.associatedParty.name"/>
          <short value="Name of associated party"/>
          <definition value="Name of associated party."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.associatedParty.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.associatedParty.role">
          <path value="ResearchStudy.associatedParty.role"/>
          <short
                 value="sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb"/>
          <definition value="Type of association."/>
          <comment
                   value="NCI has study roles defined - M11 only requires a limited set of these"/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.associatedParty.role"/>
            <min value="1"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.associatedParty.period">
          <path value="ResearchStudy.associatedParty.period"/>
          <short value="When active in the role"/>
          <definition
                      value="Identifies the start date and the end date of the associated party in the role."/>
          <comment
                   value="The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.associatedParty.period"/>
            <min value="0"/>
            <max value="*"/>
          </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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.associatedParty.classifier">
          <path value="ResearchStudy.associatedParty.classifier"/>
          <short
                 value="nih | fda | government | nonprofit | academic | industry"/>
          <definition
                      value="A categorization other than role for the associated party."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.associatedParty.classifier"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ResearchStudyPartyOrganizationType"/>
            </extension>
            <strength value="example"/>
            <description value="A characterization or type of the entity."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-party-organization-type|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.associatedParty.party">
          <path value="ResearchStudy.associatedParty.party"/>
          <short
                 value="Individual or organization associated with study (use practitionerRole to specify their organisation)"/>
          <definition
                      value="Individual or organization associated with study (use practitionerRole to specify their organisation)."/>
          <comment
                   value="Suggestions of a better attribute name are appreciated"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.associatedParty.party"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Practitioner|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/PractitionerRole|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Organization|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.associatedParty.party.id">
          <path value="ResearchStudy.associatedParty.party.id"/>
          <representation value="xmlAttr"/>
          <short value="Unique id for inter-element referencing"/>
          <definition
                      value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Element.id"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
              <valueUrl value="id"/>
            </extension>
            <code value="http://hl7.org/fhirpath/System.String"/>
          </type>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.party.extension">
          <path value="ResearchStudy.associatedParty.party.extension"/>
          <slicing>
            <discriminator>
              <type value="value"/>
              <path value="url"/>
            </discriminator>
            <description value="Extensions are always sliced by (at least) url"/>
            <rules value="open"/>
          </slicing>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.party.reference">
          <path value="ResearchStudy.associatedParty.party.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-2"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="true"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.party.type">
          <path value="ResearchStudy.associatedParty.party.type"/>
          <short
                 value="Type the reference refers to (e.g. &quot;Patient&quot;) - must be a resource in resources"/>
          <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 known RESTful URL) or by resolving the target of the reference."/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="FHIRResourceTypeExt"/>
            </extension>
            <strength value="extensible"/>
            <description
                         value="Aa resource (or, for logical models, the URI of the logical model)."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/resource-types|6.0.0-ballot3"/>
          </binding>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.party.identifier">
          <path value="ResearchStudy.associatedParty.party.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).

    This element only allows for a single identifier. In the case where additional identifiers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="Reference.identifier"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Identifier"/>
          </type>
          <condition value="ref-2"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value=".identifier"/>
          </mapping>
        </element>
        <element id="ResearchStudy.associatedParty.party.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.associatedParty.party.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>
          <condition value="ref-2"/>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="N/A"/>
          </mapping>
        </element>
        <element id="ResearchStudy.progressStatus">
          <path value="ResearchStudy.progressStatus"/>
          <short value="Status of study with time for that status"/>
          <definition value="Status of study with time for that status."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.progressStatus"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.progressStatus.id">
          <path value="ResearchStudy.progressStatus.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.progressStatus.extension">
          <path value="ResearchStudy.progressStatus.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.progressStatus.modifierExtension">
          <path value="ResearchStudy.progressStatus.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.progressStatus.state">
          <path value="ResearchStudy.progressStatus.state"/>
          <short value="Label for status or state (e.g. recruitment status)"/>
          <definition
                      value="Label for status or state (e.g. recruitment status)."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.progressStatus.state"/>
            <min value="1"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="ResearchStudyStudyStatus"/>
            </extension>
            <strength value="extensible"/>
            <description value="defn."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-status|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.progressStatus.actual">
          <path value="ResearchStudy.progressStatus.actual"/>
          <short value="Actual if true else anticipated"/>
          <definition
                      value="An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.progressStatus.actual"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="boolean"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.progressStatus.period">
          <path value="ResearchStudy.progressStatus.period"/>
          <short value="Date range"/>
          <definition value="Date range."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.progressStatus.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.whyStopped">
          <path value="ResearchStudy.whyStopped"/>
          <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.whyStopped"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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|6.0.0-ballot3"/>
          </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.recruitment">
          <path value="ResearchStudy.recruitment"/>
          <short
                 value="Target or actual group of participants enrolled in study"/>
          <definition
                      value="Target or actual group of participants enrolled in study."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.recruitment"/>
            <min value="0"/>
            <max value="1"/>
          </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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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>
        </element>
        <element id="ResearchStudy.recruitment.id">
          <path value="ResearchStudy.recruitment.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.recruitment.extension">
          <path value="ResearchStudy.recruitment.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.recruitment.modifierExtension">
          <path value="ResearchStudy.recruitment.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.recruitment.targetNumber">
          <path value="ResearchStudy.recruitment.targetNumber"/>
          <short value="Estimated total number of participants to be enrolled"/>
          <definition
                      value="Estimated total number of participants to be enrolled."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.recruitment.targetNumber"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="unsignedInt"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.recruitment.actualNumber">
          <path value="ResearchStudy.recruitment.actualNumber"/>
          <short value="Actual total number of participants enrolled in study"/>
          <definition
                      value="Actual total number of participants enrolled in study."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.recruitment.actualNumber"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="unsignedInt"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.recruitment.eligibility">
          <path value="ResearchStudy.recruitment.eligibility"/>
          <short value="Inclusion and exclusion criteria"/>
          <definition
                      value="Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.recruitment.eligibility"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.recruitment.actualGroup">
          <path value="ResearchStudy.recruitment.actualGroup"/>
          <short value="Group of participants who were enrolled in study"/>
          <definition
                      value="Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.recruitment.actualGroup"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <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>
        </element>
        <element id="ResearchStudy.comparisonGroup">
          <path value="ResearchStudy.comparisonGroup"/>
          <short value="Defined path through the study for a subject"/>
          <definition
                      value="Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}."/>
          <comment
                   value="In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups."/>
          <alias value="arm"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.comparisonGroup"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.comparisonGroup.id">
          <path value="ResearchStudy.comparisonGroup.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.comparisonGroup.extension">
          <path value="ResearchStudy.comparisonGroup.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.comparisonGroup.modifierExtension">
          <path value="ResearchStudy.comparisonGroup.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.comparisonGroup.targetNumber">
          <path value="ResearchStudy.comparisonGroup.targetNumber"/>
          <short
                 value="Estimated total number of participants to be enrolled in the comparison group"/>
          <definition
                      value="Estimated total number of participants to be enrolled in the comparison group."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.comparisonGroup.targetNumber"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="unsignedInt"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.comparisonGroup.actualNumber">
          <path value="ResearchStudy.comparisonGroup.actualNumber"/>
          <short
                 value="Actual total number of participants enrolled in the comparison group"/>
          <definition
                      value="Actual total number of participants enrolled in the comparison group."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.comparisonGroup.actualNumber"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="unsignedInt"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.comparisonGroup.eligibility">
          <path value="ResearchStudy.comparisonGroup.eligibility"/>
          <short
                 value="Inclusion and exclusion criteria for the comparison group"/>
          <definition
                      value="Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.comparisonGroup.eligibility"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.comparisonGroup.observedGroup">
          <path value="ResearchStudy.comparisonGroup.observedGroup"/>
          <short
                 value="Group of participants who were enrolled in the comparison group"/>
          <definition
                      value="Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.comparisonGroup.observedGroup"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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>
          <condition value="ele-1"/>
          <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"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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|6.0.0-ballot3"/>
          </binding>
          <mapping>
            <identity value="BRIDG5.1"/>
            <map value="StudyObjective.typeCode"/>
          </mapping>
        </element>
        <element id="ResearchStudy.objective.description">
          <path value="ResearchStudy.objective.description"/>
          <short value="Description of the objective"/>
          <definition
                      value="Free text description of the objective of the study.  This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description)."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure">
          <path value="ResearchStudy.objective.outcomeMeasure"/>
          <short value="A variable measured during the study"/>
          <definition
                      value="An &quot;outcome measure&quot;, &quot;endpoint&quot;, &quot;effect measure&quot; or &quot;measure of effect&quot; is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment."/>
          <comment
                   value="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="ResearchStudy.objective.outcomeMeasure"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.id">
          <path value="ResearchStudy.objective.outcomeMeasure.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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.extension">
          <path value="ResearchStudy.objective.outcomeMeasure.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.modifierExtension">
          <path value="ResearchStudy.objective.outcomeMeasure.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 managable, 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://build.fhir.org/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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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.outcomeMeasure.name">
          <path value="ResearchStudy.objective.outcomeMeasure.name"/>
          <short value="Label for the outcome measure"/>
          <definition value="Label for the outcome measure."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.type">
          <path value="ResearchStudy.objective.outcomeMeasure.type"/>
          <short value="primary | secondary | exploratory"/>
          <definition value="The kind of outcome measure."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </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="defn."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/research-study-objective-type|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.description">
          <path value="ResearchStudy.objective.outcomeMeasure.description"/>
          <short value="Description of the outcome measure"/>
          <definition value="Description of the outcome measure."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.endpoint">
          <path value="ResearchStudy.objective.outcomeMeasure.endpoint"/>
          <short value="Definition of the outcome measure"/>
          <definition value="Definition of the outcome measure."/>
          <min value="1"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.endpoint"/>
            <min value="1"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/EvidenceVariable|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.population">
          <path value="ResearchStudy.objective.outcomeMeasure.population"/>
          <short value="Population for this estimand"/>
          <definition value="Population for this estimand."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.population"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.intervention">
          <path value="ResearchStudy.objective.outcomeMeasure.intervention"/>
          <short value="Comparison group of interest"/>
          <definition value="Comparison group of interest."/>
          <comment
                   value="To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.intervention"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.comparator">
          <path value="ResearchStudy.objective.outcomeMeasure.comparator"/>
          <short value="Comparison group for comparison"/>
          <definition value="Comparison group for comparison."/>
          <comment
                   value="To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id"/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.comparator"/>
            <min value="0"/>
            <max value="1"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Group|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.summaryMeasure">
          <path value="ResearchStudy.objective.outcomeMeasure.summaryMeasure"/>
          <short value="Statistical measure for treatment effect estimate"/>
          <definition value="Statistical measure for treatment effect estimate."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.summaryMeasure"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <binding>
            <extension
                       url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
              <valueString value="StatisticType"/>
            </extension>
            <strength value="example"/>
            <description
                         value="The type of a statistic, e.g. relative risk or mean."/>
            <valueSet
                      value="http://hl7.org/fhir/ValueSet/statistic-type|6.0.0-ballot3"/>
          </binding>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.eventHandling">
          <path value="ResearchStudy.objective.outcomeMeasure.eventHandling"/>
          <short value="Handling of intercurrent event"/>
          <definition value="Handling of intercurrent event."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.objective.outcomeMeasure.eventHandling"/>
            <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 or both"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.eventHandling.id">
          <path value="ResearchStudy.objective.outcomeMeasure.eventHandling.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"/>
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          </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>
          <condition value="ele-1"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
          <mapping>
            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="ResearchStudy.objective.outcomeMeasure.eventHandling.extension">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.extension"/>
          <short value="Additional content defined by implementations"/>
          <definition
                      value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, 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."/>
          <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."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <isModifier value="false"/>
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            <identity value="rim"/>
            <map value="n/a"/>
          </mapping>
        </element>
        <element
                 id="ResearchStudy.objective.outcomeMeasure.eventHandling.modifierExtension">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.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 managable, 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://build.fhir.org/extensibility.html#modifierExtension)."/>
          <alias value="extensions"/>
          <alias value="user content"/>
          <alias value="modifiers"/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="BackboneElement.modifierExtension"/>
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          <type>
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          <constraint>
            <key value="ele-1"/>
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            <human value="All FHIR elements must have a @value or children"/>
            <expression
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            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
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          <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.outcomeMeasure.eventHandling.event">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.event"/>
          <short value="The event"/>
          <definition value="The event."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="ResearchStudy.objective.outcomeMeasure.eventHandling.event"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.objective.outcomeMeasure.eventHandling.group">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.group"/>
          <short value="The group that is affected by this event handling"/>
          <definition value="The group that is affected by this event handling."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="ResearchStudy.objective.outcomeMeasure.eventHandling.group"/>
            <min value="0"/>
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          </base>
          <type>
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          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element
                 id="ResearchStudy.objective.outcomeMeasure.eventHandling.handling">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.handling"/>
          <short value="How the data is handled"/>
          <definition value="How the data is handled."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="ResearchStudy.objective.outcomeMeasure.eventHandling.handling"/>
            <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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element
                 id="ResearchStudy.objective.outcomeMeasure.eventHandling.description">
          <path
                value="ResearchStudy.objective.outcomeMeasure.eventHandling.description"/>
          <short value="Text summary of event handling"/>
          <definition value="Text summary of event handling."/>
          <min value="0"/>
          <max value="1"/>
          <base>
            <path
                  value="ResearchStudy.objective.outcomeMeasure.eventHandling.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())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="false"/>
        </element>
        <element id="ResearchStudy.result">
          <path value="ResearchStudy.result"/>
          <short value="Link to results generated during the study"/>
          <definition
                      value="Link to one or more sets of results generated by the study.  Could also link to a research registry holding the results such as ClinicalTrials.gov."/>
          <min value="0"/>
          <max value="*"/>
          <base>
            <path value="ResearchStudy.result"/>
            <min value="0"/>
            <max value="*"/>
          </base>
          <type>
            <code value="Reference"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Citation|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Composition|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/DiagnosticReport|6.0.0-ballot3"/>
            <targetProfile
                           value="http://hl7.org/fhir/StructureDefinition/Evidence|6.0.0-ballot3"/>
          </type>
          <constraint>
            <key value="ele-1"/>
            <severity value="error"/>
            <human value="All FHIR elements must have a @value or children"/>
            <expression
                        value="hasValue() or (children().count() &gt; id.count())"/>
            <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
          </constraint>
          <mustSupport value="false"/>
          <isModifier value="false"/>
          <isSummary value="true"/>
        </element>
      </snapshot>
      <differential>
        <element id="ResearchStudy">
          <path value="ResearchStudy"/>
          <constraint>
            <key value="identifier-required"/>
            <severity value="error"/>
            <human
                   value="The identifier MUST be populated with at least a Sponsor identifier"/>
            <expression value="identifier.exists()"/>
            <source
                    value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"/>
          </constraint>
        </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="1"/>
        </element>
        <element id="ResearchStudy.extension:narrative">
          <path value="ResearchStudy.extension"/>
          <sliceName value="narrative"/>
          <min value="0"/>
          <max value="*"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.extension:amendment">
          <path value="ResearchStudy.extension"/>
          <sliceName value="amendment"/>
          <min value="0"/>
          <max value="1"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.extension:confidentialityStatement">
          <path value="ResearchStudy.extension"/>
          <sliceName value="confidentialityStatement"/>
          <min value="0"/>
          <max value="1"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement"/>
          </type>
        </element>
        <element id="ResearchStudy.extension:approval">
          <path value="ResearchStudy.extension"/>
          <sliceName value="approval"/>
          <min value="0"/>
          <max value="1"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.extension:m11-research-study">
          <path value="ResearchStudy.extension"/>
          <sliceName value="m11-research-study"/>
          <min value="1"/>
          <max value="1"/>
          <type>
            <code value="Extension"/>
            <profile
                     value="http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"/>
          </type>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.identifier">
          <path value="ResearchStudy.identifier"/>
          <min value="1"/>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.identifier.type">
          <path value="ResearchStudy.identifier.type"/>
          <min value="1"/>
          <mustSupport value="true"/>
          <isModifier value="true"/>
          <isModifierReason
                            value="Protocols may have multiple business identifers from a given system - only with a type can they be distinguished."/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.identifier.type.coding.code">
          <path value="ResearchStudy.identifier.type.coding.code"/>
          <min value="1"/>
        </element>
        <element id="ResearchStudy.title">
          <path value="ResearchStudy.title"/>
          <comment
                   value="The protocol should have a descriptive title that identifies the scientific aspects of the trial sufficiently to ensure it is immediately evident what the trial is investigating and on whom, and to allow retrieval from literature or internet searches."/>
          <mustSupport value="true"/>
        </element>
        <element id="ResearchStudy.label.type">
          <path value="ResearchStudy.label.type"/>
          <comment value="The value set used here is defined by CDISC/DDF"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.relatesTo.type">
          <path value="ResearchStudy.relatesTo.type"/>
          <comment
                   value="Set to a value of predecessor to indicate the target is the previous version of the protocol or to C218694
                                to indicate the target is the amendment details that have been incorporated"/>
        </element>
        <element id="ResearchStudy.phase">
          <path value="ResearchStudy.phase"/>
          <comment
                   value="M11 has specified its own preferred terms rather than NCI terms and these should be provided in the display element of the coding."/>
          <mustSupport value="true"/>
          <binding>
            <strength value="required"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.focus">
          <path value="ResearchStudy.focus"/>
          <comment
                   value="Expect MedicinalProductDefinition.name.type.code to be one of C71898 Proprietary name or C97054 Non-proprietary name"/>
        </element>
        <element id="ResearchStudy.associatedParty.role">
          <path value="ResearchStudy.associatedParty.role"/>
          <comment
                   value="NCI has study roles defined - M11 only requires a limited set of these"/>
          <binding>
            <strength value="extensible"/>
            <valueSet
                      value="http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs"/>
          </binding>
        </element>
        <element id="ResearchStudy.associatedParty.party.reference">
          <path value="ResearchStudy.associatedParty.party.reference"/>
          <mustSupport value="true"/>
        </element>
      </differential>
    </StructureDefinition>