<StructureDefinition xmlns="http://hl7.org/fhir">
  <meta>
    <lastUpdated value="2017-12-20T15:12:36.724+01:00" />
  </meta>
  <url value="http://clinicalsite.org/fhir/StructureDefinition/researchsubject-soa" />
  <name value="researchsubject-soa" />
  <status value="draft" />
  <date value="2017-12-12T17:15:09.041+01:00" />
  <fhirVersion value="3.0.1" />
  <kind value="resource" />
  <abstract value="false" />
  <type value="ResearchSubject" />
  <baseDefinition value="http://hl7.org/fhir/StructureDefinition/ResearchSubject" />
  <derivation value="constraint" />
  <differential>
    <element id="ResearchSubject.extension">
      <path value="ResearchSubject.extension" />
      <slicing>
        <discriminator>
          <type value="value" />
          <path value="url" />
        </discriminator>
        <rules value="open" />
      </slicing>
    </element>
    <element id="ResearchSubject.extension:statusHistory">
      <path value="ResearchSubject.extension" />
      <sliceName value="statusHistory" />
      <type>
        <code value="Extension" />
        <profile value="http://clinicalsite.org/fhir/StructureDefinition/researchsubject-status-history" />
      </type>
    </element>
    <element id="ResearchSubject.extension:comment">
      <path value="ResearchSubject.extension" />
      <sliceName value="comment" />
      <max value="1" />
      <type>
        <code value="Extension" />
        <profile value="http://clinicalsite.org/fhir/StructureDefinition/researchsubject-comment" />
      </type>
    </element>
    <element id="ResearchSubject.identifier">
      <path value="ResearchSubject.identifier" />
      <slicing>
        <discriminator>
          <type value="value" />
          <path value="type.coding.code" />
        </discriminator>
        <rules value="closed" />
      </slicing>
      <comment value="In STU3, identifier is restricted to a maximum cardinality of 1. This is relaxed to * in R4.&#xD;&#xA;For this profile, two identifiers are requires to capture the Screening and the Subject ID." />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier.type">
      <path value="ResearchSubject.identifier.type" />
      <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" />
        <valueSetUri value="http://hl7.org/fhir/ValueSet/identifier-type" />
      </binding>
    </element>
    <element id="ResearchSubject.identifier.type.coding">
      <path value="ResearchSubject.identifier.type.coding" />
      <binding>
        <strength value="extensible" />
        <valueSetUri value="http://hl7.org/fhir/ValueSet/identifier-type" />
      </binding>
    </element>
    <element id="ResearchSubject.identifier:ScreeningID">
      <path value="ResearchSubject.identifier" />
      <sliceName value="ScreeningID" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:ScreeningID.type">
      <path value="ResearchSubject.identifier.type" />
      <min value="1" />
    </element>
    <element id="ResearchSubject.identifier:ScreeningID.type.coding.system">
      <path value="ResearchSubject.identifier.type.coding.system" />
      <fixedUri value="http://clinicalsite.org/fhir/CodeSystem/researchsubject-identifier-type" />
    </element>
    <element id="ResearchSubject.identifier:ScreeningID.type.coding.code">
      <path value="ResearchSubject.identifier.type.coding.code" />
      <fixedCode value="SCREEN" />
    </element>
    <element id="ResearchSubject.identifier:ScreeningID.value">
      <path value="ResearchSubject.identifier.value" />
      <min value="1" />
    </element>
    <element id="ResearchSubject.identifier:SubjectID">
      <path value="ResearchSubject.identifier" />
      <sliceName value="SubjectID" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.identifier:SubjectID.type">
      <path value="ResearchSubject.identifier.type" />
      <min value="1" />
    </element>
    <element id="ResearchSubject.identifier:SubjectID.type.coding.system">
      <path value="ResearchSubject.identifier.type.coding.system" />
      <fixedUri value="http://clinicalsite.org/fhir/CodeSystem/researchsubject-identifier-type" />
    </element>
    <element id="ResearchSubject.identifier:SubjectID.type.coding.code">
      <path value="ResearchSubject.identifier.type.coding.code" />
      <fixedCode value="SUBJ" />
    </element>
    <element id="ResearchSubject.identifier:SubjectID.value">
      <path value="ResearchSubject.identifier.value" />
      <min value="1" />
    </element>
    <element id="ResearchSubject.status">
      <path value="ResearchSubject.status" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.period">
      <path value="ResearchSubject.period" />
      <short value="Start and end of clinical trial process" />
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.period.start">
      <path value="ResearchSubject.period.start" />
      <min value="1" />
    </element>
    <element id="ResearchSubject.study">
      <path value="ResearchSubject.study" />
      <type>
        <code value="Reference" />
        <targetProfile value="http://clinicalsites.org/fhir/StructureDefinition/researchstudy-soa" />
        <aggregation value="referenced" />
        <aggregation value="bundled" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.study.reference">
      <path value="ResearchSubject.study.reference" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.individual">
      <path value="ResearchSubject.individual" />
      <type>
        <code value="Reference" />
        <targetProfile value="http://clinicalsite.org/fhir/StructureDefinition/patient-soa" />
        <aggregation value="referenced" />
        <aggregation value="bundled" />
      </type>
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.individual.reference">
      <path value="ResearchSubject.individual.reference" />
      <min value="1" />
      <mustSupport value="true" />
    </element>
    <element id="ResearchSubject.assignedArm">
      <path value="ResearchSubject.assignedArm" />
      <max value="0" />
    </element>
    <element id="ResearchSubject.actualArm">
      <path value="ResearchSubject.actualArm" />
      <max value="0" />
    </element>
    <element id="ResearchSubject.consent">
      <path value="ResearchSubject.consent" />
      <type>
        <code value="Reference" />
        <targetProfile value="http://clinicalsite.org/fhir/StructureDefinition/consent-soa" />
        <aggregation value="referenced" />
        <aggregation value="contained" />
      </type>
      <mustSupport value="true" />
    </element>
  </differential>
</StructureDefinition>