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Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative |
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Definition for Code SystemResearchSubjectState
@prefix fhir: <http://hl7.org/fhir/> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . # - resource ------------------------------------------------------------------- [] a fhir:CodeSystem; fhir:Resource.id [ fhir:value "research-subject-state"]; fhir:Resource.meta [ fhir:Meta.lastUpdated [ fhir:value "2022-09-10T05:52:37.223+11:00" ]; fhir:Meta.profile [ fhir:value "http://hl7.org/fhir/StructureDefinition/shareablecodesystem" ] ]; fhir:DomainResource.text [ fhir:Narrative.status [ fhir:value "generated" ] ]; fhir:DomainResource.extension [ fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg" ]; fhir:Extension.value [ fhir:value "brr" ] ], [ fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status" ]; fhir:Extension.value [ fhir:value "draft" ] ], [ fhir:Extension.url [ fhir:value "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm" ]; fhir:Extension.value [ fhir:value "1" ] ]; fhir:CanonicalResource.url [ fhir:value "http://terminology.hl7.org/CodeSystem/research-subject-state"]; fhir:CanonicalResource.identifier [ fhir:Identifier.system [ fhir:value "urn:ietf:rfc:3986" ]; fhir:Identifier.value [ fhir:value "urn:oid:2.16.840.1.113883.4.642.4.2007" ] ]; fhir:CanonicalResource.version [ fhir:value "5.0.0-ballot"]; fhir:CanonicalResource.name [ fhir:value "ResearchSubjectState"]; fhir:CanonicalResource.title [ fhir:value "ResearchSubjectState"]; fhir:CanonicalResource.status [ fhir:value "draft"]; fhir:CanonicalResource.experimental [ fhir:value "false"]; fhir:CanonicalResource.date [ fhir:value "2020-12-28T16:55:11+11:00"]; fhir:CanonicalResource.publisher [ fhir:value "HL7 (FHIR Project)"]; fhir:CanonicalResource.contact [ fhir:ContactDetail.telecom [ fhir:ContactPoint.system [ fhir:value "url" ]; fhir:ContactPoint.value [ fhir:value "http://hl7.org/fhir" ] ], [ fhir:ContactPoint.system [ fhir:value "email" ]; fhir:ContactPoint.value [ fhir:value "fhir@lists.hl7.org" ] ] ]; fhir:CanonicalResource.description [ fhir:value "Indicates the progression of a study subject through a study."]; fhir:CodeSystem.url [ fhir:value "http://terminology.hl7.org/CodeSystem/research-subject-state"]; fhir:CodeSystem.identifier [ fhir:Identifier.system [ fhir:value "urn:ietf:rfc:3986" ]; fhir:Identifier.value [ fhir:value "urn:oid:2.16.840.1.113883.4.642.4.2007" ] ]; fhir:CodeSystem.version [ fhir:value "5.0.0-ballot"]; fhir:CodeSystem.name [ fhir:value "ResearchSubjectState"]; fhir:CodeSystem.title [ fhir:value "ResearchSubjectState"]; fhir:CodeSystem.status [ fhir:value "draft"]; fhir:CodeSystem.experimental [ fhir:value "false"]; fhir:CodeSystem.date [ fhir:value "2020-12-28T16:55:11+11:00"]; fhir:CodeSystem.publisher [ fhir:value "HL7 (FHIR Project)"]; fhir:CodeSystem.contact [ fhir:ContactDetail.telecom [ fhir:ContactPoint.system [ fhir:value "url" ]; fhir:ContactPoint.value [ fhir:value "http://hl7.org/fhir" ] ], [ fhir:ContactPoint.system [ fhir:value "email" ]; fhir:ContactPoint.value [ fhir:value "fhir@lists.hl7.org" ] ] ]; fhir:CodeSystem.description [ fhir:value "Indicates the progression of a study subject through a study."]; fhir:CodeSystem.caseSensitive [ fhir:value "true"]; fhir:CodeSystem.valueSet [ fhir:value "http://hl7.org/fhir/ValueSet/research-subject-state"]; fhir:CodeSystem.content [ fhir:value "complete"]; fhir:CodeSystem.concept [ fhir:ConceptDefinitionComponent.code [ fhir:value "candidate" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Candidate" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "An identified person that can be considered for inclusion in a study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "eligible" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Eligible" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person that has met the eligibility criteria for inclusion in a study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "follow-up" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Follow-up" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person is no longer receiving study intervention and/or being evaluated with tests and procedures according to the protocol, but they are being monitored on a protocol-prescribed schedule." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "ineligible" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Ineligible" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person who did not meet one or more criteria required for participation in a study is considered to have failed screening or\nis ineligible for the study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "not-registered" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Not Registered" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person for whom registration was not completed." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "off-study" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Off-study" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person that has ended their participation on a study either because their treatment/observation is complete or through not\nresponding, withdrawal, non-compliance and/or adverse event." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "on-study" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "On-study" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person that is enrolled or registered on a study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "on-study-intervention" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "On-study-intervention" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "The person is receiving the treatment or participating in an activity (e.g. yoga, diet, etc.) that the study is evaluating." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "on-study-observation" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "On-study-observation" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "The subject is being evaluated via tests and assessments according to the study calendar, but is not receiving any intervention. Note that this state is study-dependent and might not exist in all studies. A synonym for this is \"short-term follow-up\"." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "pending-on-study" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Pending on-study" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person is pre-registered for a study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "potential-candidate" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Potential Candidate" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person that is potentially eligible for participation in the study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "screening" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Screening" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "A person who is being evaluated for eligibility for a study." ] ], [ fhir:ConceptDefinitionComponent.code [ fhir:value "withdrawn" ]; fhir:ConceptDefinitionComponent.display [ fhir:value "Withdrawn" ]; fhir:ConceptDefinitionComponent.definition [ fhir:value "The person has withdrawn their participation in the study before registration." ] ] . # -------------------------------------------------------------------------------------
Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.
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