Shared Data Model for Research Study - XML Representation - NCPI FHIR Implementation Guide v2 v0.1.0

NCPI FHIR Implementation Guide v2 - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Logical Model: CdmResearchStudy - XML Profile

Draft as of 2024-03-21
XML representation of the SharedDataModelResearchStudy logical model.
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<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="SharedDataModelResearchStudy"/>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><table border="0" cellpadding="0" cellspacing="0" style="border: 0px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top;"><tr style="border: 1px #F0F0F0 solid; font-size: 11px; font-family: verdana; vertical-align: top"><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="The logical name of the element">Name</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Information about the use of the element">Flags</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Minimum and Maximum # of times the the element can appear in the instance">Card.</a></th><th style="width: 100px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Reference to the type of the element">Type</a></th><th style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Additional information about the element">Description &amp; Constraints</a><span style="float: right"><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck1.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy" title="The **Shared Data Model for Research Study** represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG.">SharedDataModelResearchStudy</a><a name="SharedDataModelResearchStudy"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://build.fhir.org/types.html#Base">Base</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Shared Data Model for Research Study<br/><span style="font-weight:bold">Instances of this logical model are not marked to be the target of a Reference</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.persistentIdentifier" title="External facing, globally unique identifier.">persistentIdentifier</a><a name="SharedDataModelResearchStudy.persistentIdentifier"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#Identifier">Identifier</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">External facing, globally unique identifier.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.parentStudy" title="Parent study, required only for substudies.">parentStudy</a><a name="SharedDataModelResearchStudy.parentStudy"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="StructureDefinition-SharedDataModelResearchStudy.html">SharedDataModelResearchStudy</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Parent study, required only for substudies.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.name" title="Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”.">name</a><a name="SharedDataModelResearchStudy.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.name.text" title="The study's name">text</a><a name="SharedDataModelResearchStudy.name.text"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The study's name</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.name.type" title="Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)">type</a><a name="SharedDataModelResearchStudy.name.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-study-name-type-vs.html" title="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-name-type-vs">Study Name Type</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.description" title="short summary of relevant and important information about the study.">description</a><a name="SharedDataModelResearchStudy.description"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">short summary of relevant and important information about the study.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.website" title="A URL for a website that provides information about the research effort as a whole.">website</a><a name="SharedDataModelResearchStudy.website"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#url">url</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A URL for a website that provides information about the research effort as a whole.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.totalParticipants" title="Number of total participants represented by the data in this study.">totalParticipants</a><a name="SharedDataModelResearchStudy.totalParticipants"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#integer">integer</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Number of total participants represented by the data in this study.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.studyFocus" title="The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred.">studyFocus</a><a name="SharedDataModelResearchStudy.studyFocus"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.studyFocus.term" title="The term used to describe the focus of the study. A valid MeSH is preferred.">term</a><a name="SharedDataModelResearchStudy.studyFocus.term"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The term used to describe the focus of the study. A valid MeSH is preferred.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.studyFocus.termSource" title="The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie).">termSource</a><a name="SharedDataModelResearchStudy.studyFocus.termSource"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie).</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.enrollmentCriteria" title="EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods.">enrollmentCriteria</a><a name="SharedDataModelResearchStudy.enrollmentCriteria"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#markdown">markdown</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.population" title="Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate.">population</a><a name="SharedDataModelResearchStudy.population"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck110.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.population.type" title="A term that specifies the population being described.">type</a><a name="SharedDataModelResearchStudy.population.type"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A term that specifies the population being described.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.population.description" title="A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy.">description</a><a name="SharedDataModelResearchStudy.population.description"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.citation" title="Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI.">citation</a><a name="SharedDataModelResearchStudy.citation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.publications" title="Provide a list of publications that use this data. This may be updated to include new publications as they are created.">publications</a><a name="SharedDataModelResearchStudy.publications"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Provide a list of publications that use this data. This may be updated to include new publications as they are created.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.additionalDocumentation" title="AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation.">additionalDocumentation</a><a name="SharedDataModelResearchStudy.additionalDocumentation"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.consortium" title="If the data in this study was gathered as part of a consortial effort, list the consortium here.">consortium</a><a name="SharedDataModelResearchStudy.consortium"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">If the data in this study was gathered as part of a consortial effort, list the consortium here.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck10.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.acknowledgements" title="Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors.">acknowledgements</a><a name="SharedDataModelResearchStudy.acknowledgements"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.personnel" title="Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided.">personnel</a><a name="SharedDataModelResearchStudy.personnel"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..*</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/backboneelement.html#BackboneElement">BackboneElement</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided.<br/></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_datatype.gif" alt="." style="background-color: white; background-color: inherit" title="Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.personnel.name" title="The name of the person being described.">name</a><a name="SharedDataModelResearchStudy.personnel.name"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#HumanName">HumanName</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The name of the person being described.</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: #F7F7F7"><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_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_primitive.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.personnel.role" title="The role of the person being described.">role</a><a name="SharedDataModelResearchStudy.personnel.role"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..1</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#code">code</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The role of the person being described.<br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-study-personnel-role-vs.html" title="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-personnel-role-vs">Study Personnel Role</a> (<a href="http://hl7.org/fhir/R5/terminologies.html#extensible" title="To be conformant, the concept in this element SHALL be from the specified value set if any of the codes within the value set can apply to the concept being communicated.  If the value set does not cover the concept (based on human review), alternate codings (or, data type allowing, text) may be included instead.">extensible</a>)</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_primitive.png" alt="." style="background-color: white; background-color: inherit" title="Primitive Data Type" class="hierarchy"/> <a href="StructureDefinition-SharedDataModelResearchStudy-definitions.html#SharedDataModelResearchStudy.personnel.organization" title="The organizational affiliation of the person being described.">organization</a><a name="SharedDataModelResearchStudy.personnel.organization"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"/><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">0..1</td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4B/datatypes.html#string">string</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">The organizational affiliation of the person being described.</td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="https://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#table-views" title="Legend for this format"><img src="data:image/png;base64,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" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
  </text>
  <url
       value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/SharedDataModelResearchStudy"/>
  <version value="0.1.0"/>
  <name value="CdmResearchStudy"/>
  <title value="Shared Data Model for Research Study"/>
  <status value="draft"/>
  <date value="2024-03-21T20:04:56+00:00"/>
  <publisher value="NCPI FHIR Working Group"/>
  <contact>
    <name value="NCPI FHIR Working Group"/>
    <telecom>
      <system value="url"/>
      <value value="http://example.org/example-publisher"/>
    </telecom>
    <telecom>
      <system value="email"/>
      <value value="ncpi-fhir-ig@googlegroups.com"/>
    </telecom>
  </contact>
  <description
               value="The **Shared Data Model for Research Study** represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG."/>
  <fhirVersion value="4.3.0"/>
  <kind value="logical"/>
  <abstract value="false"/>
  <type
        value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/SharedDataModelResearchStudy"/>
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/Base"/>
  <derivation value="specialization"/>
  <snapshot>
    <element id="SharedDataModelResearchStudy">
      <path value="SharedDataModelResearchStudy"/>
      <short value="Shared Data Model for Research Study"/>
      <definition
                  value="The **Shared Data Model for Research Study** represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="Base"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <isModifier value="false"/>
    </element>
    <element id="SharedDataModelResearchStudy.persistentIdentifier">
      <path value="SharedDataModelResearchStudy.persistentIdentifier"/>
      <short value="External facing, globally unique identifier."/>
      <definition value="External facing, globally unique identifier."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.persistentIdentifier"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Identifier"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.parentStudy">
      <path value="SharedDataModelResearchStudy.parentStudy"/>
      <short value="Parent study, required only for substudies."/>
      <definition value="Parent study, required only for substudies."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.parentStudy"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code
              value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/SharedDataModelResearchStudy"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.name">
      <path value="SharedDataModelResearchStudy.name"/>
      <short
             value="Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”."/>
      <definition
                  value="Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”."/>
      <min value="1"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.name"/>
        <min value="1"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
    </element>
    <element id="SharedDataModelResearchStudy.name.id">
      <path value="SharedDataModelResearchStudy.name.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.name.extension">
      <path value="SharedDataModelResearchStudy.name.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 manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <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())"/>
        <xpath value="@value|f:*|h:div"/>
        <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()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.name.modifierExtension">
      <path value="SharedDataModelResearchStudy.name.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </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="SharedDataModelResearchStudy.name.text">
      <path value="SharedDataModelResearchStudy.name.text"/>
      <short value="The study's name"/>
      <definition value="The study's name"/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.name.text"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.name.type">
      <path value="SharedDataModelResearchStudy.name.type"/>
      <short
             value="Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)"/>
      <definition
                  value="Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.name.type"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-name-type-vs"/>
      </binding>
    </element>
    <element id="SharedDataModelResearchStudy.description">
      <path value="SharedDataModelResearchStudy.description"/>
      <short
             value="short summary of relevant and important information about the study."/>
      <definition
                  value="short summary of relevant and important information about the study."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.description"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.website">
      <path value="SharedDataModelResearchStudy.website"/>
      <short
             value="A URL for a website that provides information about the research effort as a whole."/>
      <definition
                  value="A URL for a website that provides information about the research effort as a whole."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.website"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="url"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.totalParticipants">
      <path value="SharedDataModelResearchStudy.totalParticipants"/>
      <short
             value="Number of total participants represented by the data in this study."/>
      <definition
                  value="Number of total participants represented by the data in this study."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.totalParticipants"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="integer"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus">
      <path value="SharedDataModelResearchStudy.studyFocus"/>
      <short
             value="The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred."/>
      <definition
                  value="The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.studyFocus"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.id">
      <path value="SharedDataModelResearchStudy.studyFocus.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.extension">
      <path value="SharedDataModelResearchStudy.studyFocus.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 manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <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())"/>
        <xpath value="@value|f:*|h:div"/>
        <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()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.modifierExtension">
      <path
            value="SharedDataModelResearchStudy.studyFocus.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </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="SharedDataModelResearchStudy.studyFocus.term">
      <path value="SharedDataModelResearchStudy.studyFocus.term"/>
      <short
             value="The term used to describe the focus of the study. A valid MeSH is preferred."/>
      <definition
                  value="The term used to describe the focus of the study. A valid MeSH is preferred."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.studyFocus.term"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.termSource">
      <path value="SharedDataModelResearchStudy.studyFocus.termSource"/>
      <short
             value="The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie)."/>
      <definition
                  value="The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie)."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.studyFocus.termSource"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.enrollmentCriteria">
      <path value="SharedDataModelResearchStudy.enrollmentCriteria"/>
      <short
             value="EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods."/>
      <definition
                  value="EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.enrollmentCriteria"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="markdown"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.population">
      <path value="SharedDataModelResearchStudy.population"/>
      <short
             value="Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate."/>
      <definition
                  value="Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.population"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
    </element>
    <element id="SharedDataModelResearchStudy.population.id">
      <path value="SharedDataModelResearchStudy.population.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.population.extension">
      <path value="SharedDataModelResearchStudy.population.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 manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <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())"/>
        <xpath value="@value|f:*|h:div"/>
        <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()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.population.modifierExtension">
      <path
            value="SharedDataModelResearchStudy.population.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </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="SharedDataModelResearchStudy.population.type">
      <path value="SharedDataModelResearchStudy.population.type"/>
      <short value="A term that specifies the population being described."/>
      <definition
                  value="A term that specifies the population being described."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.population.type"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.population.description">
      <path value="SharedDataModelResearchStudy.population.description"/>
      <short
             value="A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy."/>
      <definition
                  value="A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.population.description"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.citation">
      <path value="SharedDataModelResearchStudy.citation"/>
      <short
             value="Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI."/>
      <definition
                  value="Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.citation"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.publications">
      <path value="SharedDataModelResearchStudy.publications"/>
      <short
             value="Provide a list of publications that use this data. This may be updated to include new publications as they are created."/>
      <definition
                  value="Provide a list of publications that use this data. This may be updated to include new publications as they are created."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.publications"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.additionalDocumentation">
      <path value="SharedDataModelResearchStudy.additionalDocumentation"/>
      <short
             value="AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation."/>
      <definition
                  value="AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.additionalDocumentation"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.consortium">
      <path value="SharedDataModelResearchStudy.consortium"/>
      <short
             value="If the data in this study was gathered as part of a consortial effort, list the consortium here."/>
      <definition
                  value="If the data in this study was gathered as part of a consortial effort, list the consortium here."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.consortium"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.acknowledgements">
      <path value="SharedDataModelResearchStudy.acknowledgements"/>
      <short
             value="Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors."/>
      <definition
                  value="Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.acknowledgements"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.personnel">
      <path value="SharedDataModelResearchStudy.personnel"/>
      <short
             value="Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided."/>
      <definition
                  value="Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided."/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="SharedDataModelResearchStudy.personnel"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="BackboneElement"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human
               value="All FHIR elements must have a @value or children unless an empty Parameters resource"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count()) or $this is Parameters"/>
        <xpath value="@value|f:*|h:div|self::f:Parameters"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.id">
      <path value="SharedDataModelResearchStudy.personnel.id"/>
      <representation value="xmlAttr"/>
      <short value="Unique id for inter-element referencing"/>
      <definition
                  value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="Element.id"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <extension
                   url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
          <valueUrl value="id"/>
        </extension>
        <code value="http://hl7.org/fhirpath/System.String"/>
      </type>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.extension">
      <path value="SharedDataModelResearchStudy.personnel.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 manageable, there is a strict set of governance  applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/>
      <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())"/>
        <xpath value="@value|f:*|h:div"/>
        <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()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </constraint>
      <isModifier value="false"/>
      <isSummary value="false"/>
      <mapping>
        <identity value="rim"/>
        <map value="n/a"/>
      </mapping>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.modifierExtension">
      <path value="SharedDataModelResearchStudy.personnel.modifierExtension"/>
      <short value="Extensions that cannot be ignored even if unrecognized"/>
      <definition
                  value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.

Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
      <comment
               value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions.  The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
      <requirements
                    value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored.  This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4B/extensibility.html#modifierExtension)."/>
      <alias value="extensions"/>
      <alias value="user content"/>
      <alias value="modifiers"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="BackboneElement.modifierExtension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression
                    value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </constraint>
      <constraint>
        <key value="ext-1"/>
        <severity value="error"/>
        <human value="Must have either extensions or value[x], not both"/>
        <expression value="extension.exists() != value.exists()"/>
        <xpath
               value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), &quot;value&quot;)])"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Extension"/>
      </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="SharedDataModelResearchStudy.personnel.name">
      <path value="SharedDataModelResearchStudy.personnel.name"/>
      <short value="The name of the person being described."/>
      <definition value="The name of the person being described."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.personnel.name"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="HumanName"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.role">
      <path value="SharedDataModelResearchStudy.personnel.role"/>
      <short value="The role of the person being described."/>
      <definition value="The role of the person being described."/>
      <min value="1"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.personnel.role"/>
        <min value="1"/>
        <max value="1"/>
      </base>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-personnel-role-vs"/>
      </binding>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.organization">
      <path value="SharedDataModelResearchStudy.personnel.organization"/>
      <short
             value="The organizational affiliation of the person being described."/>
      <definition
                  value="The organizational affiliation of the person being described."/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="SharedDataModelResearchStudy.personnel.organization"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="string"/>
      </type>
    </element>
  </snapshot>
  <differential>
    <element id="SharedDataModelResearchStudy">
      <path value="SharedDataModelResearchStudy"/>
      <short value="Shared Data Model for Research Study"/>
      <definition
                  value="The **Shared Data Model for Research Study** represents the understanding of what a Research Study is from the context of users and authors of the NCPI FHIR IG."/>
    </element>
    <element id="SharedDataModelResearchStudy.persistentIdentifier">
      <path value="SharedDataModelResearchStudy.persistentIdentifier"/>
      <short value="External facing, globally unique identifier."/>
      <definition value="External facing, globally unique identifier."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="Identifier"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.parentStudy">
      <path value="SharedDataModelResearchStudy.parentStudy"/>
      <short value="Parent study, required only for substudies."/>
      <definition value="Parent study, required only for substudies."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code
              value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/StructureDefinition/SharedDataModelResearchStudy"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.name">
      <path value="SharedDataModelResearchStudy.name"/>
      <short
             value="Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”."/>
      <definition
                  value="Name is a repeatable object that consists of sets of two fields.  All ResearchStudy records must have at least one Name object with Name.Type=”formal title”."/>
      <min value="1"/>
      <max value="*"/>
      <type>
        <code value="BackboneElement"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.name.text">
      <path value="SharedDataModelResearchStudy.name.text"/>
      <short value="The study's name"/>
      <definition value="The study's name"/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.name.type">
      <path value="SharedDataModelResearchStudy.name.type"/>
      <short
             value="Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)"/>
      <definition
                  value="Type of name or title this name relates to (formal-title, internale-name, familiar-name, etc)"/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-name-type-vs"/>
      </binding>
    </element>
    <element id="SharedDataModelResearchStudy.description">
      <path value="SharedDataModelResearchStudy.description"/>
      <short
             value="short summary of relevant and important information about the study."/>
      <definition
                  value="short summary of relevant and important information about the study."/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.website">
      <path value="SharedDataModelResearchStudy.website"/>
      <short
             value="A URL for a website that provides information about the research effort as a whole."/>
      <definition
                  value="A URL for a website that provides information about the research effort as a whole."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="url"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.totalParticipants">
      <path value="SharedDataModelResearchStudy.totalParticipants"/>
      <short
             value="Number of total participants represented by the data in this study."/>
      <definition
                  value="Number of total participants represented by the data in this study."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="integer"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus">
      <path value="SharedDataModelResearchStudy.studyFocus"/>
      <short
             value="The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred."/>
      <definition
                  value="The primary focus(es) of the study. This can include terms related to disease area, intervention, drug, device, or other focus. MeSH terms are preferred."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="BackboneElement"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.term">
      <path value="SharedDataModelResearchStudy.studyFocus.term"/>
      <short
             value="The term used to describe the focus of the study. A valid MeSH is preferred."/>
      <definition
                  value="The term used to describe the focus of the study. A valid MeSH is preferred."/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.studyFocus.termSource">
      <path value="SharedDataModelResearchStudy.studyFocus.termSource"/>
      <short
             value="The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie)."/>
      <definition
                  value="The source ontology or vocabulary for subjectFocus.Term (optional if term uses curie)."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.enrollmentCriteria">
      <path value="SharedDataModelResearchStudy.enrollmentCriteria"/>
      <short
             value="EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods."/>
      <definition
                  value="EnrollmentCriteria describes the inclusion and exclusion criteria used to enroll participants in this study. This can be provided as a free text description, but may also be structured using bullets, tables, or other organizational methods."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="markdown"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.population">
      <path value="SharedDataModelResearchStudy.population"/>
      <short
             value="Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate."/>
      <definition
                  value="Population is a repeatable object that consists of sets of two fields. Population provides an overall description of the general population enrolled in the study, including basic demographics at a minimum and other useful population descriptors as appropriate."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="BackboneElement"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.population.type">
      <path value="SharedDataModelResearchStudy.population.type"/>
      <short value="A term that specifies the population being described."/>
      <definition
                  value="A term that specifies the population being described."/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.population.description">
      <path value="SharedDataModelResearchStudy.population.description"/>
      <short
             value="A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy."/>
      <definition
                  value="A free text field that provides more information about the population specified in PopulationType within the context of this researchStudy."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.citation">
      <path value="SharedDataModelResearchStudy.citation"/>
      <short
             value="Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI."/>
      <definition
                  value="Provide any relevant information regarding how to cite this study. This can be as specific as including a full citation or as simple as a DOI."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.publications">
      <path value="SharedDataModelResearchStudy.publications"/>
      <short
             value="Provide a list of publications that use this data. This may be updated to include new publications as they are created."/>
      <definition
                  value="Provide a list of publications that use this data. This may be updated to include new publications as they are created."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.additionalDocumentation">
      <path value="SharedDataModelResearchStudy.additionalDocumentation"/>
      <short
             value="AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation."/>
      <definition
                  value="AdditionalDocumentation should be used to provide URLs, citations, or other appropriate references to technical documentation that is important for understanding the data included in this study. This can include data dictionaries, methods descriptions, github repositories, case report forms (CRFs), or any other relevant documentation."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.consortium">
      <path value="SharedDataModelResearchStudy.consortium"/>
      <short
             value="If the data in this study was gathered as part of a consortial effort, list the consortium here."/>
      <definition
                  value="If the data in this study was gathered as part of a consortial effort, list the consortium here."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.acknowledgements">
      <path value="SharedDataModelResearchStudy.acknowledgements"/>
      <short
             value="Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors."/>
      <definition
                  value="Acknowledgements describes any attribution or acknowledgements relevant to the study.  This can include but is not limited to funding sources, organizational affiliations or sponsors."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="string"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.personnel">
      <path value="SharedDataModelResearchStudy.personnel"/>
      <short
             value="Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided."/>
      <definition
                  value="Every study must have at least one Primary Contact defined. Additional personnel such as Primary Investigator(s), Administrator(s), Collaborator(s) or other roles may also be included. If there are no appropriate individuals who can serve as primary contact for a study, an organization may be provided."/>
      <min value="0"/>
      <max value="*"/>
      <type>
        <code value="BackboneElement"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.name">
      <path value="SharedDataModelResearchStudy.personnel.name"/>
      <short value="The name of the person being described."/>
      <definition value="The name of the person being described."/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="HumanName"/>
      </type>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.role">
      <path value="SharedDataModelResearchStudy.personnel.role"/>
      <short value="The role of the person being described."/>
      <definition value="The role of the person being described."/>
      <min value="1"/>
      <max value="1"/>
      <type>
        <code value="code"/>
      </type>
      <binding>
        <strength value="extensible"/>
        <valueSet
                  value="https://nih-ncpi.github.io/ncpi-fhir-ig-2/ValueSet/study-personnel-role-vs"/>
      </binding>
    </element>
    <element id="SharedDataModelResearchStudy.personnel.organization">
      <path value="SharedDataModelResearchStudy.personnel.organization"/>
      <short
             value="The organizational affiliation of the person being described."/>
      <definition
                  value="The organizational affiliation of the person being described."/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="string"/>
      </type>
    </element>
  </differential>
</StructureDefinition>