{"resourceType":"CodeSystem","id":"research-study-phase","meta":{"lastUpdated":"2021-01-17T07:06:13.533+11:00"},"extension":[{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-wg","valueCode":"brr"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status","valueCode":"draft"},{"url":"http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm","valueInteger":1}],"url":"http://terminology.hl7.org/CodeSystem/research-study-phase","identifier":[{"system":"urn:ietf:rfc:3986","value":"urn:oid:2.16.840.1.113883.4.642.4.1247"}],"version":"4.0.1","name":"ResearchStudyPhase","title":"ResearchStudyPhase","status":"draft","experimental":false,"date":"2021-01-17T07:06:13+11:00","publisher":"HL7 (FHIR Project)","contact":[{"telecom":[{"system":"url","value":"http://hl7.org/fhir"},{"system":"email","value":"fhir@lists.hl7.org"}]}],"description":"Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.","caseSensitive":true,"valueSet":"http://hl7.org/fhir/ValueSet/research-study-phase","content":"complete","concept":[{"code":"n-a","display":"N/A","definition":"Trials without phases (for example, studies of devices or behavioral interventions)."},{"code":"early-phase-1","display":"Early Phase 1","definition":"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."},{"code":"phase-1","display":"Phase 1","definition":"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."},{"code":"phase-1-phase-2","display":"Phase 1/Phase 2","definition":"Trials that are a combination of phases 1 and 2."},{"code":"phase-2","display":"Phase 2","definition":"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."},{"code":"phase-2-phase-3","display":"Phase 2/Phase 3","definition":"Trials that are a combination of phases 2 and 3."},{"code":"phase-3","display":"Phase 3","definition":"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."},{"code":"phase-4","display":"Phase 4","definition":"Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use."}]}