http://terminology.hl7.org/CodeSystem/research-study-phase|4.0.1
name
ResearchStudyPhase
ResearchStudyPhase
package
hl7.fhir.r4.examples@4.0.1
hl7.fhir.r4.examples@4.0.1
content
complete
complete
status
draft
draft
date
2019-10-31 22:29:23.0
2019-10-31 22:29:23.0
ResearchStudyPhase
Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
{
"description" : "Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.",
"compose" : null,
"package" : "hl7.fhir.r4.examples@4.0.1",
"date" : "2019-10-31T22:29:23Z",
"meta" : {
"lastUpdated" : "2019-11-01T09:29:23.356+11:00"
},
"publisher" : "HL7 (FHIR Project)",
"content" : "complete",
"name" : "ResearchStudyPhase",
"experimental" : false,
"resourceType" : "CodeSystem",
"title" : "ResearchStudyPhase",
"supliment" : null,
"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
} ],
"status" : "draft",
"id" : "67f99b2b-6cde-5256-b6e8-0d3be10821c9",
"valueSet" : "http://hl7.org/fhir/ValueSet/research-study-phase",
"url" : "http://terminology.hl7.org/CodeSystem/research-study-phase",
"identifier" : [ {
"value" : "urn:oid:2.16.840.1.113883.4.642.4.1247",
"system" : "urn:ietf:rfc:3986"
} ],
"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."
} ],
"caseSensitive" : true,
"version" : "4.0.1",
"contact" : [ {
"telecom" : [ {
"value" : "http://hl7.org/fhir",
"system" : "url"
}, {
"value" : "fhir@lists.hl7.org",
"system" : "email"
} ]
} ]
}