<?xml version="1.0" encoding="UTF-8"?> | |
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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="ResearchSubject" type="ResearchSubject"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">A physical entity which is the primary unit of operational and/or administrative interest in a study.</xs:documentation> | |
</xs:annotation> | |
</xs:element> | |
<xs:complexType name="ResearchSubject"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">A physical entity which is the primary unit of operational and/or administrative interest in a 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="ResearchSubjectStatus"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">The current state 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="individual" minOccurs="1" maxOccurs="1" type="Reference"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">The record of the person or animal who is involved in the study.</xs:documentation> | |
</xs:annotation> | |
</xs:element> | |
<xs:element name="assignedArm" minOccurs="0" maxOccurs="1" type="string"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">The name of the arm in the study the subject is expected to follow as part of this study.</xs:documentation> | |
</xs:annotation> | |
</xs:element> | |
<xs:element name="actualArm" minOccurs="0" maxOccurs="1" type="string"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">The name of the arm in the study the subject actually followed as part of this study.</xs:documentation> | |
</xs:annotation> | |
</xs:element> | |
<xs:element name="consent" minOccurs="0" maxOccurs="1" type="Reference"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">A record of the patient's informed agreement to participate in the study.</xs:documentation> | |
</xs:annotation> | |
</xs:element> | |
</xs:sequence> | |
</xs:extension> | |
</xs:complexContent> | |
</xs:complexType> | |
<xs:simpleType name="ResearchSubjectStatus-list"> | |
<xs:restriction base="code-primitive"> | |
<xs:enumeration value="candidate"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Candidate</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="eligible"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Eligible</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="follow-up"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Follow-up</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="ineligible"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Ineligible</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="not-registered"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Not Registered</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="off-study"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Off-study</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="on-study"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">On-study</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="on-study-intervention"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">On-study-intervention</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="on-study-observation"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">On-study-observation</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="pending-on-study"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Pending on-study</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="potential-candidate"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Potential Candidate</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="screening"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Screening</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
<xs:enumeration value="withdrawn"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Withdrawn</xs:documentation> | |
</xs:annotation> | |
</xs:enumeration> | |
</xs:restriction> | |
</xs:simpleType> | |
<xs:complexType name="ResearchSubjectStatus"> | |
<xs:annotation> | |
<xs:documentation xml:lang="en">Indicates the progression of a study subject through a 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="Element"> | |
<xs:attribute name="value" type="ResearchSubjectStatus-list" use="optional"/> | |
</xs:extension> | |
</xs:complexContent> | |
</xs:complexType> | |
</xs:schema> |