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  Generated on Sun, Mar 26, 2023 15:21+1100 for FHIR v5.0.0 

  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.

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<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="ResearchStudy" type="ResearchStudy">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
  </xs:element>
  <xs:complexType name="ResearchStudy">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</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="url" minOccurs="0" maxOccurs="1" type="uri">
            <xs:annotation>
              <xs:documentation xml:lang="en">Canonical identifier for this study resource, represented as a globally unique URI.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="identifier" minOccurs="0" maxOccurs="unbounded" type="Identifier">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifiers assigned to this research study by the sponsor or other systems.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="version" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The business version for the study record.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Name for this study (computer friendly).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="title" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The human readable name of the research study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="label" type="ResearchStudy.Label" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Additional names for the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="protocol" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The set of steps expected to be performed as part of the execution of the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="partOf" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A larger research study of which this particular study is a component or step.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="relatedArtifact" minOccurs="0" maxOccurs="unbounded" type="RelatedArtifact">
            <xs:annotation>
              <xs:documentation xml:lang="en">Citations, references, URLs and other related documents.  When using relatedArtifact to share URLs, the relatedArtifact.type will often be set to one of &quot;documentation&quot; or &quot;supported-with&quot; and the URL value will often be in relatedArtifact.document.url but another possible location is relatedArtifact.resource when it is a canonical URL.</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 (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.</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 study).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="primaryPurposeType" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The type of study based upon the intent of the study activities. A classification of the intent of the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="phase" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="studyDesign" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="focus" minOccurs="0" maxOccurs="unbounded" type="CodeableReference">
            <xs:annotation>
              <xs:documentation xml:lang="en">The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="condition" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The condition that is the focus of the study.  For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion &quot;healthy volunteer&quot;, but the target condition code would be a Lupus SNOMED code.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="keyword" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Key terms to aid in searching for or filtering the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="region" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A country, state or other area where the study is taking place rather than its precise geographic location or address.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="descriptionSummary" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A brief text for explaining the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A detailed and human-readable narrative of the study. E.g., study abstract.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="period" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifies the start date and the expected (or actual, depending on status) end date for the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="site" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">A facility in which study activities are conducted.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="note" minOccurs="0" maxOccurs="unbounded" type="Annotation">
            <xs:annotation>
              <xs:documentation xml:lang="en">Comments made about the study by the performer, subject or other participants.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="classifier" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="associatedParty" type="ResearchStudy.AssociatedParty" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Sponsors, collaborators, and other parties.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="progressStatus" type="ResearchStudy.ProgressStatus" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Status of study with time for that status.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="whyStopped" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A description and/or code explaining the premature termination of the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="recruitment" type="ResearchStudy.Recruitment" minOccurs="0" maxOccurs="1">
            <xs:annotation>
              <xs:documentation xml:lang="en">Target or actual group of participants enrolled in study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="comparisonGroup" type="ResearchStudy.ComparisonGroup" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="objective" type="ResearchStudy.Objective" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="outcomeMeasure" type="ResearchStudy.OutcomeMeasure" minOccurs="0" maxOccurs="unbounded">
            <xs:annotation>
              <xs:documentation xml:lang="en">An &quot;outcome measure&quot;, &quot;endpoint&quot;, &quot;effect measure&quot; or &quot;measure of effect&quot; is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="result" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Link to one or more sets of results generated by the study.  Could also link to a research registry holding the results such as ClinicalTrials.gov.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.Label">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Kind of name.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="value" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">The name.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.AssociatedParty">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Name of associated party.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="role" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Type of association.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="period" minOccurs="0" maxOccurs="unbounded" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Identifies the start date and the end date of the associated party in the role.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="classifier" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">A categorization other than role for the associated party.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="party" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Individual or organization associated with study (use practitionerRole to specify their organisation).</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.ProgressStatus">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="state" minOccurs="1" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Label for status or state (e.g. recruitment status).</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="actual" minOccurs="0" maxOccurs="1" type="boolean">
            <xs:annotation>
              <xs:documentation xml:lang="en">An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="period" minOccurs="0" maxOccurs="1" type="Period">
            <xs:annotation>
              <xs:documentation xml:lang="en">Date range.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.Recruitment">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="targetNumber" minOccurs="0" maxOccurs="1" type="unsignedInt">
            <xs:annotation>
              <xs:documentation xml:lang="en">Estimated total number of participants to be enrolled.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="actualNumber" minOccurs="0" maxOccurs="1" type="unsignedInt">
            <xs:annotation>
              <xs:documentation xml:lang="en">Actual total number of participants enrolled in study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="eligibility" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Inclusion and exclusion criteria.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="actualGroup" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Group of participants who were enrolled in study.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.ComparisonGroup">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="linkId" minOccurs="0" maxOccurs="1" type="id">
            <xs:annotation>
              <xs:documentation xml:lang="en">Allows the comparisonGroup for the study and the comparisonGroup for the subject to be linked easily.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="name" minOccurs="1" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Unique, human-readable label for this comparisonGroup of the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">Categorization of study comparisonGroup, e.g. experimental, active comparator, placebo comparater.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">A succinct description of the path through the study that would be followed by a subject adhering to this comparisonGroup.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="intendedExposure" minOccurs="0" maxOccurs="unbounded" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Interventions or exposures in this comparisonGroup or cohort.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="observedGroup" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Group of participants who were enrolled in study comparisonGroup.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.Objective">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Unique, human-readable label for this objective of the study.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="1" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The kind of study objective.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">Free text description of the objective of the study.  This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
  <xs:complexType name="ResearchStudy.OutcomeMeasure">
    <xs:annotation>
      <xs:documentation xml:lang="en">A scientific study of nature that sometimes includes processes involved in health and disease. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.</xs:documentation>
    </xs:annotation>
    <xs:complexContent>
      <xs:extension base="BackboneElement">
        <xs:sequence>
          <xs:element name="name" minOccurs="0" maxOccurs="1" type="string">
            <xs:annotation>
              <xs:documentation xml:lang="en">Label for the outcome.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="type" minOccurs="0" maxOccurs="unbounded" type="CodeableConcept">
            <xs:annotation>
              <xs:documentation xml:lang="en">The parameter or characteristic being assessed as one of the values by which the study is assessed.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="description" minOccurs="0" maxOccurs="1" type="markdown">
            <xs:annotation>
              <xs:documentation xml:lang="en">Description of the outcome.</xs:documentation>
           </xs:annotation>
          </xs:element>
          <xs:element name="reference" minOccurs="0" maxOccurs="1" type="Reference">
            <xs:annotation>
              <xs:documentation xml:lang="en">Structured outcome definition.</xs:documentation>
           </xs:annotation>
          </xs:element>
        </xs:sequence>
      </xs:extension>
    </xs:complexContent>
  </xs:complexType>
</xs:schema>
