@prefix fhir: . @prefix owl: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:CodeSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "research-study-phase"] ; # fhir:meta [ fhir:lastUpdated [ fhir:v "2020-04-09T21:10:28.568+00:00"^^xsd:dateTime ] ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "
Placeholder
" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ; fhir:value [ fhir:v "brr" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ; fhir:value [ fhir:v "1"^^xsd:integer ] ] ) ; # fhir:url [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI] ; # fhir:identifier ( [ fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ; fhir:value [ fhir:v "urn:oid:2.16.840.1.113883.4.642.1.1247" ] ] ) ; # fhir:version [ fhir:v "0.1.0"] ; # fhir:name [ fhir:v "ResearchStudyPhase"] ; # fhir:title [ fhir:v "ResearchStudyPhase"] ; # fhir:status [ fhir:v "draft"] ; # fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # fhir:date [ fhir:v "2020-04-09T21:10:28+00:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "HL7 (FHIR Project)"] ; # fhir:contact ( [ fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "http://hl7.org/fhir" ] ] [ fhir:system [ fhir:v "email" ] ; fhir:value [ fhir:v "fhir@lists.hl7.org" ] ] ) ] ) ; # fhir:description [ fhir:v "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."] ; # fhir:caseSensitive [ fhir:v "true"^^xsd:boolean] ; # fhir:valueSet [ fhir:v "http://terminology.hl7.org/ValueSet/research-study-phase"^^xsd:anyURI ; fhir:link ] ; # fhir:content [ fhir:v "complete"] ; # fhir:concept ( [ fhir:code [ fhir:v "n-a" ] ; fhir:display [ fhir:v "N/A" ] ; fhir:definition [ fhir:v "Trials without phases (for example, studies of devices or behavioral interventions)." ] ] [ fhir:code [ fhir:v "early-phase-1" ] ; fhir:display [ fhir:v "Early Phase 1" ] ; fhir:definition [ fhir:v "Designation for optional exploratory trials conducted in accordance with the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies. Formerly called Phase 0." ] ] [ fhir:code [ fhir:v "phase-1" ] ; fhir:display [ fhir:v "Phase 1" ] ; fhir:definition [ fhir:v "Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients." ] ] [ fhir:code [ fhir:v "phase-1-phase-2" ] ; fhir:display [ fhir:v "Phase 1/Phase 2" ] ; fhir:definition [ fhir:v "Trials that are a combination of phases 1 and 2." ] ] [ fhir:code [ fhir:v "phase-2" ] ; fhir:display [ fhir:v "Phase 2" ] ; fhir:definition [ fhir:v "Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks." ] ] [ fhir:code [ fhir:v "phase-2-phase-3" ] ; fhir:display [ fhir:v "Phase 2/Phase 3" ] ; fhir:definition [ fhir:v "Trials that are a combination of phases 2 and 3." ] ] [ fhir:code [ fhir:v "phase-3" ] ; fhir:display [ fhir:v "Phase 3" ] ; fhir:definition [ fhir:v "Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug." ] ] [ fhir:code [ fhir:v "phase-4" ] ; fhir:display [ fhir:v "Phase 4" ] ; fhir:definition [ fhir:v "Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use." ] ] ) . # # -------------------------------------------------------------------------------------