Genomics Clinical Picture Repository Implementation Guide
0.1.0 - ci-build
Genomics Clinical Picture Repository Implementation Guide - Local Development build (v0.1.0). See the Directory of published versions
| Active as of 2022-03-21 |
XML representation of the GencliprResearchSubject resource profile.
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="GencliprResearchSubject"/>
<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="http://hl7.org/fhir/R4/formats.html#table" 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="http://hl7.org/fhir/R4/formats.html#table" 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="http://hl7.org/fhir/R4/formats.html#table" 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="http://hl7.org/fhir/R4/formats.html#table" 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="http://hl7.org/fhir/R4/formats.html#table" title="Additional information about the element">Description & Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 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_resource.png" alt="." style="background-color: white; background-color: inherit" title="Resource" class="hierarchy"/> <a href="StructureDefinition-GencliprResearchSubject-definitions.html#ResearchSubject">ResearchSubject</a><a name="ResearchSubject"> </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://hl7.org/fhir/R4/researchsubject.html">ResearchSubject</a></td><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">Physical entity which is the primary unit of interest in the study</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_bck11.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-GencliprResearchSubject-definitions.html#ResearchSubject.identifier">identifier</a><a name="ResearchSubject.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"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">1..<span style="opacity: 0.5">*</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/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"><span style="opacity: 0.5">Business Identifier for research subject in a study</span></td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck101.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_element.gif" alt="." style="background-color: white; background-color: inherit" title="Element" class="hierarchy"/> <a href="StructureDefinition-GencliprResearchSubject-definitions.html#ResearchSubject.identifier.type">type</a><a name="ResearchSubject.identifier.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"><span style="opacity: 0.5">0</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/datatypes.html#CodeableConcept">CodeableConcept</a></td><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">Description of identifier</span><br/><span style="font-weight:bold">Required Pattern: </span><span style="color: darkgreen">At least the following</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_bck1001.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#CodeableConcept.coding">coding</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/R4/datatypes.html#Coding">Coding</a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Code defined by a terminology system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">(complex)</span></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_bck10010.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: white; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Coding.system">system</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/R4/datatypes.html#uri">uri</a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy">Identity of the terminology system<br/><span style="font-weight: bold">Fixed Value: </span><a style="color: darkgreen" href="http://terminology.hl7.org/3.1.0/CodeSystem-v2-0203.html">http://terminology.hl7.org/CodeSystem/v2-0203</a></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_bck10000.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vline.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_blank.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin_end.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_fixed.gif" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Fixed Value" class="hierarchy"/> <a href="http://hl7.org/fhir/R4/datatypes-definitions.html#Coding.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"/><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/R4/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">Symbol in syntax defined by the system<br/><span style="font-weight: bold">Fixed Value: </span><span style="color: darkgreen">PI</span></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_reference.png" alt="." style="background-color: white; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-GencliprResearchSubject-definitions.html#ResearchSubject.study">study</a><a name="ResearchSubject.study"> </a></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-GencliprResearchStudy.html">Genomics Clinical Picture Repository Research Study</a>)</td><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">Study subject is part of</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_bck00.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_reference.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Reference to another Resource" class="hierarchy"/> <a href="StructureDefinition-GencliprResearchSubject-definitions.html#ResearchSubject.individual">individual</a><a name="ResearchSubject.individual"> </a></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="padding-left: 3px; padding-right: 3px; color: white; background-color: red" title="This element must be supported">S</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">1</span><span style="opacity: 0.5">..</span><span style="opacity: 0.5">1</span></td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a href="http://hl7.org/fhir/R4/references.html">Reference</a>(<a href="StructureDefinition-DeidentifiedPatient.html">Deidentified Patient</a>)</td><td style="vertical-align: top; text-align : left; background-color: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><span style="opacity: 0.5">Who is part of study</span></td></tr>
<tr><td colspan="5" class="hierarchy"><br/><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/> Documentation for this format</a></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-category">
<valueString value="Specialized.Public Health &amp; Research"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category">
<valueCode value="patient"/>
</extension>
<url
value="http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/GencliprResearchSubject"/>
<version value="0.1.0"/>
<name value="GencliprResearchSubject"/>
<title value="Genomics Clinical Picture Repository Research Subject"/>
<status value="active"/>
<date value="2022-03-21T00:46:36+00:00"/>
<publisher value="The Australian e-Health Research Centre"/>
<contact>
<name value="The Australian e-Health Research Centre"/>
<telecom>
<system value="url"/>
<value value="https://aehrc.com"/>
</telecom>
<telecom>
<system value="email"/>
<value value="ontoserver-support@csiro.au"/>
</telecom>
</contact>
<description
value="This resource represents a patient that is the subject of a research study."/>
<copyright
value="[Australian Genomics](https://www.australiangenomics.org.au)"/>
<fhirVersion value="4.0.1"/>
<mapping>
<identity value="BRIDG5.1"/>
<uri value="https://bridgmodel.nci.nih.gov"/>
<name value="BRIDG 5.1 Mapping"/>
</mapping>
<mapping>
<identity value="v2"/>
<uri value="http://hl7.org/v2"/>
<name value="HL7 v2 Mapping"/>
</mapping>
<mapping>
<identity value="rim"/>
<uri value="http://hl7.org/v3"/>
<name value="RIM Mapping"/>
</mapping>
<mapping>
<identity value="w5"/>
<uri value="http://hl7.org/fhir/fivews"/>
<name value="FiveWs Pattern Mapping"/>
</mapping>
<kind value="resource"/>
<abstract value="false"/>
<type value="ResearchSubject"/>
<baseDefinition
value="http://hl7.org/fhir/StructureDefinition/ResearchSubject"/>
<derivation value="constraint"/>
<snapshot>
<element id="ResearchSubject">
<path value="ResearchSubject"/>
<short
value="Physical entity which is the primary unit of interest in the study"/>
<definition
value="A physical entity which is the primary unit of operational and/or administrative interest in a study."/>
<comment value="Need to make sure we encompass public health studies."/>
<alias value="Study Subject"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="ResearchSubject"/>
<min value="0"/>
<max value="*"/>
</base>
<constraint>
<key value="dom-2"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/>
<expression value="contained.contained.empty()"/>
<xpath value="not(parent::f:contained and f:contained)"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-3"/>
<severity value="error"/>
<human
value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/>
<expression
value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/>
<xpath
value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-4"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/>
<expression
value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/>
<xpath
value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<key value="dom-5"/>
<severity value="error"/>
<human
value="If a resource is contained in another resource, it SHALL NOT have a security label"/>
<expression value="contained.meta.security.empty()"/>
<xpath value="not(exists(f:contained/*/f:meta/f:security))"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<constraint>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation">
<valueMarkdown
value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/>
</extension>
<key value="dom-6"/>
<severity value="warning"/>
<human value="A resource should have narrative for robust management"/>
<expression value="text.`div`.exists()"/>
<xpath value="exists(f:text/h:div)"/>
<source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Entity. Role, or Act"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject"/>
</mapping>
<mapping>
<identity value="v2"/>
<map value="OBX"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Observation[classCode=CLNTRL, moodCode=EVN]"/>
</mapping>
</element>
<element id="ResearchSubject.id">
<path value="ResearchSubject.id"/>
<short value="Logical id of this artifact"/>
<definition
value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/>
<comment
value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.meta">
<path value="ResearchSubject.meta"/>
<short value="Metadata about the resource"/>
<definition
value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.meta"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Meta"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.implicitRules">
<path value="ResearchSubject.implicitRules"/>
<short value="A set of rules under which this content was created"/>
<definition
value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/>
<comment
value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.implicitRules"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/>
<isSummary value="true"/>
</element>
<element id="ResearchSubject.language">
<path value="ResearchSubject.language"/>
<short value="Language of the resource content"/>
<definition value="The base language in which the resource is written."/>
<comment
value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Resource.language"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet">
<valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="Language"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="preferred"/>
<description value="A human language."/>
<valueSet value="http://hl7.org/fhir/ValueSet/languages"/>
</binding>
</element>
<element id="ResearchSubject.text">
<path value="ResearchSubject.text"/>
<short value="Text summary of the resource, for human interpretation"/>
<definition
value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
<comment
value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/>
<alias value="narrative"/>
<alias value="html"/>
<alias value="xhtml"/>
<alias value="display"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="DomainResource.text"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Narrative"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="Act.text?"/>
</mapping>
</element>
<element id="ResearchSubject.contained">
<path value="ResearchSubject.contained"/>
<short value="Contained, inline Resources"/>
<definition
value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/>
<comment
value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/>
<alias value="inline resources"/>
<alias value="anonymous resources"/>
<alias value="contained resources"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.contained"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Resource"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchSubject.extension">
<path value="ResearchSubject.extension"/>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource. 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="DomainResource.extension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > 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(.), "value")])"/>
<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="ResearchSubject.modifierExtension">
<path value="ResearchSubject.modifierExtension"/>
<short value="Extensions that cannot be ignored"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions.
Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/>
<comment
value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/>
<requirements
value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/>
<alias value="extensions"/>
<alias value="user content"/>
<min value="0"/>
<max value="*"/>
<base>
<path value="DomainResource.modifierExtension"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Extension"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > 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(.), "value")])"/>
<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 resource that contains them"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="N/A"/>
</mapping>
</element>
<element id="ResearchSubject.identifier">
<path value="ResearchSubject.identifier"/>
<short value="Business Identifier for research subject in a study"/>
<definition
value="Identifiers assigned to this research subject for a study."/>
<min value="1"/>
<max value="*"/>
<base>
<path value="ResearchSubject.identifier"/>
<min value="0"/>
<max value="*"/>
</base>
<type>
<code value="Identifier"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.identifier"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject > Subject.identifier"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".identifier"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.id">
<path value="ResearchSubject.identifier.id"/>
<representation value="xmlAttr"/>
<short value="Unique id for inter-element referencing"/>
<definition
value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Element.id"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<extension
url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type">
<valueUrl value="string"/>
</extension>
<code value="http://hl7.org/fhirpath/System.String"/>
</type>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="rim"/>
<map value="n/a"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.extension">
<path value="ResearchSubject.identifier.extension"/>
<slicing>
<discriminator>
<type value="value"/>
<path value="url"/>
</discriminator>
<description value="Extensions are always sliced by (at least) url"/>
<rules value="open"/>
</slicing>
<short value="Additional content defined by implementations"/>
<definition
value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and 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() > 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(.), "value")])"/>
<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="ResearchSubject.identifier.use">
<path value="ResearchSubject.identifier.use"/>
<short value="usual | official | temp | secondary | old (If known)"/>
<definition value="The purpose of this identifier."/>
<comment
value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/>
<requirements
value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.use"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierUse"/>
</extension>
<strength value="required"/>
<description
value="Identifies the purpose for this identifier, if known ."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|4.0.1"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="N/A"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.type">
<path value="ResearchSubject.identifier.type"/>
<short value="Description of identifier"/>
<definition
value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/>
<comment
value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/>
<requirements
value="Allows users to make use of identifiers when the identifier system is not known."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.type"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="CodeableConcept"/>
</type>
<patternCodeableConcept>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="PI"/>
</coding>
</patternCodeableConcept>
<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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="IdentifierType"/>
</extension>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-isCommonBinding">
<valueBoolean value="true"/>
</extension>
<strength value="extensible"/>
<description
value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/>
<valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/>
</binding>
<mapping>
<identity value="v2"/>
<map value="CX.5"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.code or implied by context"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.system">
<path value="ResearchSubject.identifier.system"/>
<short value="The namespace for the identifier value"/>
<definition
value="Establishes the namespace for the value - that is, a URL that describes a set values that are unique."/>
<comment value="Identifier.system is always case sensitive."/>
<requirements
value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.system"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="uri"/>
</type>
<example>
<label value="General"/>
<valueUri value="http://www.acme.com/identifiers/patient"/>
</example>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / EI-2-4"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="II.root or Role.id.root"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierType"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.value">
<path value="ResearchSubject.identifier.value"/>
<short value="The value that is unique"/>
<definition
value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/>
<comment
value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension](http://hl7.org/fhir/R4/extension-rendered-value.html). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.value"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<example>
<label value="General"/>
<valueString value="123456"/>
</example>
<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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.1 / EI.1"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./Value"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.period">
<path value="ResearchSubject.identifier.period"/>
<short value="Time period when id is/was valid for use"/>
<definition
value="Time period during which identifier is/was valid for use."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.7 + CX.8"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value="Role.effectiveTime or implied by context"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./StartDate and ./EndDate"/>
</mapping>
</element>
<element id="ResearchSubject.identifier.assigner">
<path value="ResearchSubject.identifier.assigner"/>
<short value="Organization that issued id (may be just text)"/>
<definition value="Organization that issued/manages the identifier."/>
<comment
value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="Identifier.assigner"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://hl7.org/fhir/StructureDefinition/Organization"/>
</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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="v2"/>
<map value="CX.4 / (CX.4,CX.9,CX.10)"/>
</mapping>
<mapping>
<identity value="rim"/>
<map
value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/>
</mapping>
<mapping>
<identity value="servd"/>
<map value="./IdentifierIssuingAuthority"/>
</mapping>
</element>
<element id="ResearchSubject.status">
<path value="ResearchSubject.status"/>
<short
value="candidate | eligible | follow-up | ineligible | not-registered | off-study | on-study | on-study-intervention | on-study-observation | pending-on-study | potential-candidate | screening | withdrawn"/>
<definition value="The current state of the subject."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.status"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="code"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="true"/>
<isModifierReason
value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/>
<isSummary value="true"/>
<binding>
<extension
url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName">
<valueString value="ResearchSubjectStatus"/>
</extension>
<strength value="required"/>
<description
value="Indicates the progression of a study subject through a study."/>
<valueSet
value="http://hl7.org/fhir/ValueSet/research-subject-status|4.0.1"/>
</binding>
<mapping>
<identity value="w5"/>
<map value="FiveWs.status"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject.statusCode"/>
</mapping>
<mapping>
<identity value="rim"/>
<map value=".status"/>
</mapping>
</element>
<element id="ResearchSubject.period">
<path value="ResearchSubject.period"/>
<short value="Start and end of participation"/>
<definition
value="The dates the subject began and ended their participation in the study."/>
<alias value="timing"/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.period"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Period"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="w5"/>
<map value="FiveWs.planned"/>
</mapping>
<mapping>
<identity value="BRIDG5.1"/>
<map value="PerformedStudySubjectMilestone.studyReferenceDateRange"/>
</mapping>
</element>
<element id="ResearchSubject.study">
<path value="ResearchSubject.study"/>
<short value="Study subject is part of"/>
<definition
value="Reference to the study the subject is participating in."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.study"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/GencliprResearchStudy"/>
</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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubjectProtocolVersionRelationship"/>
</mapping>
</element>
<element id="ResearchSubject.individual">
<path value="ResearchSubject.individual"/>
<short value="Who is part of study"/>
<definition
value="The record of the person or animal who is involved in the study."/>
<min value="1"/>
<max value="1"/>
<base>
<path value="ResearchSubject.individual"/>
<min value="1"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile
value="http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/DeidentifiedPatient"/>
</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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<mustSupport value="true"/>
<isModifier value="false"/>
<isSummary value="true"/>
<mapping>
<identity value="BRIDG5.1"/>
<map value="StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.assignedArm">
<path value="ResearchSubject.assignedArm"/>
<short value="What path should be followed"/>
<definition
value="The name of the arm in the study the subject is expected to follow as part of this study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.assignedArm"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.actualArm">
<path value="ResearchSubject.actualArm"/>
<short value="What path was followed"/>
<definition
value="The name of the arm in the study the subject actually followed as part of this study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.actualArm"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="string"/>
</type>
<constraint>
<key value="ele-1"/>
<severity value="error"/>
<human value="All FHIR elements must have a @value or children"/>
<expression value="hasValue() or (children().count() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="Arm > ExperimentalUnit > BiologicEntity > Subject > StudySubject"/>
</mapping>
</element>
<element id="ResearchSubject.consent">
<path value="ResearchSubject.consent"/>
<short value="Agreement to participate in study"/>
<definition
value="A record of the patient's informed agreement to participate in the study."/>
<min value="0"/>
<max value="1"/>
<base>
<path value="ResearchSubject.consent"/>
<min value="0"/>
<max value="1"/>
</base>
<type>
<code value="Reference"/>
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Consent"/>
</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() > id.count())"/>
<xpath value="@value|f:*|h:div"/>
<source value="http://hl7.org/fhir/StructureDefinition/Element"/>
</constraint>
<isModifier value="false"/>
<isSummary value="false"/>
<mapping>
<identity value="BRIDG5.1"/>
<map
value="ResearchStudy.consent is related to PerformedStudySubjectMilestone.informedConsentIndicator in that the informedConsentIndicator can be derived from the data in the Consent resource."/>
</mapping>
</element>
</snapshot>
<differential>
<element id="ResearchSubject">
<path value="ResearchSubject"/>
</element>
<element id="ResearchSubject.identifier">
<path value="ResearchSubject.identifier"/>
<min value="1"/>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.identifier.type">
<path value="ResearchSubject.identifier.type"/>
<patternCodeableConcept>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="PI"/>
</coding>
</patternCodeableConcept>
</element>
<element id="ResearchSubject.study">
<path value="ResearchSubject.study"/>
<type>
<code value="Reference"/>
<targetProfile
value="http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/GencliprResearchStudy"/>
</type>
<mustSupport value="true"/>
</element>
<element id="ResearchSubject.individual">
<path value="ResearchSubject.individual"/>
<type>
<code value="Reference"/>
<targetProfile
value="http://aehrc.github.io/genclipr-fhir-ig/StructureDefinition/DeidentifiedPatient"/>
</type>
<mustSupport value="true"/>
</element>
</differential>
</StructureDefinition>