<?xml version="1.0" encoding="UTF-8"?>
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/*
  Copyright (c) 2011+, HL7, Inc.
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  are permitted provided that the following conditions are met:
  
   * Redistributions of source code must retain the above copyright notice, this 
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     endorse or promote products derived from this software without specific 
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  INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT 
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  Generated on Mon, Mar 9, 2026 22:30+0000 for FHIR v6.0.0-ballot4 

  Note: the schemas &amp; schematrons do not contain all of the rules about what makes resources
  valid. Implementers will still need to be familiar with the content of the specification and with
  any profiles that apply to the resources in order to make a conformant implementation.

-->
<xs:schema xmlns:xs="http://www.w3.org/2001/XMLSchema" xmlns="http://hl7.org/fhir" xmlns:xhtml="http://www.w3.org/1999/xhtml" targetNamespace="http://hl7.org/fhir" elementFormDefault="qualified" version="1.0">
  <xs:include schemaLocation="fhir-base.xsd"/>
  <xs:element name="ResearchSubject" type="ResearchSubject">
    <xs:annotation>
      <xs:documentation xml:lang="en">A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="ResearchSubject">
    <xs:annotation>
      <xs:documentation xml:lang="en">A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.</xs:documentation>
      <xs:documentation xml:lang="en">If the element is present, it must have either a @value, an @id, or extensions</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="DomainResource">
        <xs:sequence>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifiers assigned to this research subject for a study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="status" minOccurs="1" maxOccurs="1" type="PublicationStatus">
            <xs:annotation>
              <xs:documentation xml:lang="en">The publication state of the resource (not of the subject).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="period" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">The dates the subject began and ended their participation in the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="study" minOccurs="1" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Reference to the study the subject is participating in.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subject" minOccurs="1" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The record of the person, animal or other entity involved in the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subjectState" type="ResearchSubject.SubjectState" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A duration in the lifecycle of the ResearchSubject within a ResearchStudy.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="subjectMilestone" type="ResearchSubject.SubjectMilestone" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A significant event in the progress of a ResearchSubject.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comparisonGroup" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A group to which the subject is assigned. This group assignment is used for administration or analysis.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="consent" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Agreement to participate in a study as well as other research agreements, e.g. to acknowledge additional risks, to agree to a protocol deviation, or to agree to more invasive validation subsidies.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchSubject.SubjectState">
    <xs:annotation>
      <xs:documentation xml:lang="en">A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="code" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifies the aspect of the subject's journey that the state refers to.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="startDate" minOccurs="1" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date a research subject entered the given state.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="endDate" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date a research subject exited or left the given state.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="reason" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The reason for the state change. If coded it should follow the formal subject state model.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchSubject.SubjectMilestone">
    <xs:annotation>
      <xs:documentation xml:lang="en">A ResearchSubject is a participant or object which is the recipient of investigative activities in a research study.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="milestone" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A specific event in the research subject's journey through a research study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="date" minOccurs="0" maxOccurs="1" type="dateTime">
            <xs:annotation>
              <xs:documentation xml:lang="en">The date/time when this milestone event was completed.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="reason" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A rationale that provides additional clarification for the milestone that was captured or documented.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
