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| Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Device, Group, Patient |
ShEx statement for researchsubject
PREFIX fhir: <http://hl7.org/fhir/>
PREFIX fhirvs: <http://hl7.org/fhir/ValueSet/>
PREFIX xsd: <http://www.w3.org/2001/XMLSchema#>
PREFIX rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#>
IMPORT <code.shex>
IMPORT <Group.shex>
IMPORT <Period.shex>
IMPORT <Device.shex>
IMPORT <Patient.shex>
IMPORT <Consent.shex>
IMPORT <Specimen.shex>
IMPORT <dateTime.shex>
IMPORT <Reference.shex>
IMPORT <Substance.shex>
IMPORT <Identifier.shex>
IMPORT <Medication.shex>
IMPORT <ResearchStudy.shex>
IMPORT <DomainResource.shex>
IMPORT <BackboneElement.shex>
IMPORT <CodeableConcept.shex>
IMPORT <CodeableReference.shex>
IMPORT <SubstanceDefinition.shex>
IMPORT <BiologicallyDerivedProduct.shex>
start=@<ResearchSubject> AND {fhir:nodeRole [fhir:treeRoot]}
# Participant or object which is the recipient of investigative activities in a study
<ResearchSubject> EXTENDS @<DomainResource> CLOSED {
a [fhir:ResearchSubject]?;fhir:nodeRole [fhir:treeRoot]?;
fhir:identifier @<OneOrMore_Identifier>?; # Business Identifier for research
# subject in a study
fhir:status @<code> AND
{fhir:v @fhirvs:publication-status}; # draft | active | retired | unknown
fhir:period @<Period>?; # Start and end of participation
fhir:study @<Reference> AND {fhir:link
@<ResearchStudy> ? }; # Study subject is part of
fhir:subject @<Reference> AND {fhir:link
@<BiologicallyDerivedProduct> OR
@<Device> OR
@<Group> OR
@<Medication> OR
@<Patient> OR
@<Specimen> OR
@<Substance> OR
@<SubstanceDefinition> ? }; # Who or what is part of study
fhir:subjectState @<OneOrMore_ResearchSubject.subjectState>?; # A duration in the lifecycle of the
# ResearchSubject within a
# ResearchStudy
fhir:subjectMilestone @<OneOrMore_ResearchSubject.subjectMilestone>?; # A significant event in the
# progress of a ResearchSubject
fhir:comparisonGroup @<OneOrMore_CodeableReference>?; # A group to which the subject is
# assigned
fhir:consent @<OneOrMore_Reference_Consent>?; # Agreement to participate in study
}
# A duration in the lifecycle of the ResearchSubject within a ResearchStudy
<ResearchSubject.subjectState> EXTENDS @<BackboneElement> CLOSED {
fhir:code @<CodeableConcept>; # candidate | in-prescreening |
# in-screening | eligible |
# ineligible | on-study |
# on-study-intervention |
# in-follow-up | off-study
fhir:startDate @<dateTime>; # The date a research subject
# entered the given state
fhir:endDate @<dateTime>?; # The date a research subject exited
# or left the given state
fhir:reason @<CodeableConcept>?; # State change reason
}
# A significant event in the progress of a ResearchSubject
<ResearchSubject.subjectMilestone> EXTENDS @<BackboneElement> CLOSED {
fhir:milestone @<CodeableConcept>;
fhir:date @<dateTime>?; # The date/time when this milestone
# event was completed
fhir:reason @<OneOrMore_CodeableConcept>?;
}
#---------------------- Cardinality Types (OneOrMore) -------------------
<OneOrMore_Identifier> CLOSED {
rdf:first @<Identifier> ;
rdf:rest [rdf:nil] OR @<OneOrMore_Identifier>
}
<OneOrMore_ResearchSubject.subjectState> CLOSED {
rdf:first @<ResearchSubject.subjectState> ;
rdf:rest [rdf:nil] OR @<OneOrMore_ResearchSubject.subjectState>
}
<OneOrMore_ResearchSubject.subjectMilestone> CLOSED {
rdf:first @<ResearchSubject.subjectMilestone> ;
rdf:rest [rdf:nil] OR @<OneOrMore_ResearchSubject.subjectMilestone>
}
<OneOrMore_CodeableReference> CLOSED {
rdf:first @<CodeableReference> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableReference>
}
<OneOrMore_Reference_Consent> CLOSED {
rdf:first @<Reference> AND {fhir:link
@<Consent> } ;
rdf:rest [rdf:nil] OR @<OneOrMore_Reference_Consent>
}
<OneOrMore_CodeableConcept> CLOSED {
rdf:first @<CodeableConcept> ;
rdf:rest [rdf:nil] OR @<OneOrMore_CodeableConcept>
}
#---------------------- Value Sets ------------------------
# The lifecycle status of an artifact.
fhirvs:publication-status ["draft" "active" "retired" "unknown"]
Usage note: every effort has been made to ensure that the ShEx files are correct and useful, but they are not a normative part of the specification.
FHIR ®© HL7.org 2011+. FHIR R6 hl7.fhir.core#6.0.0-ballot3 generated on Fri, Oct 31, 2025 22:08+0000.
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