Smart Bear Implementation Guide
3.2.2 - ci-build

Smart Bear Implementation Guide - Local Development build (v3.2.2). See the Directory of published versions

Resource Profile: SmartBearResearchSubject - XML Profile

Active as of 2022-05-25

XML representation of the SmartBearResearchSubject resource profile.

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<StructureDefinition xmlns="http://hl7.org/fhir">
  <id value="SmartBearResearchSubject"/>
  <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 &amp; Constraints</a><span style="float: right"><a href="http://hl7.org/fhir/R4/formats.html#table" title="Legend for this format"><img src="http://hl7.org/fhir/R4/help16.png" alt="doco" style="background-color: inherit"/></a></span></th></tr><tr style="border: 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-SmartBearResearchSubject-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_bck12.png)" class="hierarchy"><img src="tbl_spacer.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="tbl_vjoin.png" alt="." style="background-color: inherit" class="hierarchy"/><img src="icon_extension_simple.png" alt="." style="background-color: #F7F7F7; background-color: inherit" title="Simple Extension" class="hierarchy"/> <a href="StructureDefinition-SmartBearResearchSubject-definitions.html#ResearchSubject.extension">Slices for extension</a><a name="ResearchSubject.extension"> </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"><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: #F7F7F7; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px" class="hierarchy"><a style="opacity: 0.5" href="http://hl7.org/fhir/R4/extensibility.html#Extension">Extension</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">Extension</span><br/><span style="font-weight:bold">Slice: </span>Unordered, Open by value:url</td></tr>
<tr style="border: 0px #F0F0F0 solid; padding:0px; vertical-align: top; background-color: white"><td style="vertical-align: top; text-align : left; background-color: white; border: 0px #F0F0F0 solid; padding:0px 4px 0px 4px; white-space: nowrap; background-image: url(tbl_bck04.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_slice_item.png" alt="." style="background-color: white; background-color: inherit" title="Slice Item" class="hierarchy"/> <a href="StructureDefinition-SmartBearResearchSubject-definitions.html#ResearchSubject.extension:sourcereferral" title="Extension URL = https://smart-bear.eu/fhir/StructureDefinition/SourceReferral">SourceReferral</a><a name="ResearchSubject.extension"> </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">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/R4/datatypes.html#Coding">Coding</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">SourceReferral</span><br/><span style="font-weight:bold">URL: </span><a href="http://hl7.org/fhir/R4/StructureDefinition-SourceReferral.html">https://smart-bear.eu/fhir/StructureDefinition/SourceReferral</a><br/><span style="font-weight:bold">Binding: </span><a href="ValueSet-REFER.html">Referral Value Set</a> (<a href="http://hl7.org/fhir/R4/terminologies.html#required" title="To be conformant, the concept in this element SHALL be from the specified value set.">required</a>)</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;amp; Research"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-security-category">
    <valueCode value="patient"/>
  </extension>
  <url
       value="https://smart-bear.eu/fhir/StructureDefinition/SmartBearResearchSubject"/>
  <version value="3.2.2"/>
  <name value="SmartBearResearchSubject"/>
  <title value="ResearchSubject for smart bear"/>
  <status value="active"/>
  <date value="2022-05-25T13:16:15+02:00"/>
  <description value="ResearchSubject of Smart Bear"/>
  <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() &gt; 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() &gt; 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() &gt; 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 &quot;clinically safe&quot; for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/>
      <comment
               value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied).  This may be necessary for data from legacy systems where information is captured as a &quot;text blob&quot; or where text is additionally entered raw or narrated and encoded information is added later."/>
      <alias value="narrative"/>
      <alias value="html"/>
      <alias value="xhtml"/>
      <alias value="display"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.text"/>
        <min value="0"/>
        <max value="1"/>
      </base>
      <type>
        <code value="Narrative"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </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"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
      <short value="Extension"/>
      <definition value="An Extension"/>
      <min value="0"/>
      <max value="*"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
      </type>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </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"/>
    </element>
    <element id="ResearchSubject.extension:sourcereferral">
      <path value="ResearchSubject.extension"/>
      <sliceName value="sourcereferral"/>
      <short value="SourceReferral"/>
      <definition value="Categorization of the source of referral"/>
      <min value="0"/>
      <max value="1"/>
      <base>
        <path value="DomainResource.extension"/>
        <min value="0"/>
        <max value="*"/>
      </base>
      <type>
        <code value="Extension"/>
        <profile
                 value="https://smart-bear.eu/fhir/StructureDefinition/SourceReferral"/>
      </type>
      <condition value="ele-1"/>
      <constraint>
        <key value="ele-1"/>
        <severity value="error"/>
        <human value="All FHIR elements must have a @value or children"/>
        <expression value="hasValue() or (children().count() &gt; id.count())"/>
        <xpath value="@value|f:*|h:div"/>
        <source value="http://hl7.org/fhir/StructureDefinition/Element"/>
      </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>
      <mustSupport value="true"/>
      <isModifier value="false"/>
    </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() &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 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="0"/>
      <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() &gt; 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.identifier"/>
      </mapping>
      <mapping>
        <identity value="BRIDG5.1"/>
        <map value="StudySubject &gt; Subject.identifier"/>
      </mapping>
      <mapping>
        <identity value="rim"/>
        <map value=".identifier"/>
      </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() &gt; 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() &gt; 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://hl7.org/fhir/StructureDefinition/ResearchStudy"/>
      </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>
      <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://hl7.org/fhir/StructureDefinition/Patient"/>
      </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>
      <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() &gt; 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 &gt; ExperimentalUnit &gt; BiologicEntity &gt; Subject &gt; 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() &gt; 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 &gt; ExperimentalUnit &gt; BiologicEntity &gt; Subject &gt; 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() &gt; 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.extension">
      <path value="ResearchSubject.extension"/>
      <slicing>
        <discriminator>
          <type value="value"/>
          <path value="url"/>
        </discriminator>
        <ordered value="false"/>
        <rules value="open"/>
      </slicing>
    </element>
    <element id="ResearchSubject.extension:sourcereferral">
      <path value="ResearchSubject.extension"/>
      <sliceName value="sourcereferral"/>
      <min value="0"/>
      <max value="1"/>
      <type>
        <code value="Extension"/>
        <profile
                 value="https://smart-bear.eu/fhir/StructureDefinition/SourceReferral"/>
      </type>
      <mustSupport value="true"/>
    </element>
  </differential>
</StructureDefinition>