{"caseSensitive":true,"concept":[{"code":"n-a","definition":"Trials without phases (for example, studies of devices or behavioral interventions).","display":"N/A"},{"code":"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.","display":"Early Phase 1"},{"code":"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.","display":"Phase 1"},{"code":"phase-1-phase-2","definition":"Trials that are a combination of phases 1 and 2.","display":"Phase 1/Phase 2"},{"code":"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.","display":"Phase 2"},{"code":"phase-2-phase-3","definition":"Trials that are a combination of phases 2 and 3.","display":"Phase 2/Phase 3"},{"code":"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.","display":"Phase 3"},{"code":"phase-4","definition":"Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.","display":"Phase 4"}],"contact":[{"telecom":[{"system":"url","value":"http://hl7.org/fhir"},{"system":"email","value":"fhir@lists.hl7.org"}]}],"content":"complete","date":"2019-11-01T09:29:23+11:00","description":"Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.","experimental":false,"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}],"id":"research-study-phase","identifier":[{"system":"urn:ietf:rfc:3986","value":"urn:oid:2.16.840.1.113883.4.642.4.1247"}],"meta":{"lastUpdated":"2019-11-01T09:29:23.356+11:00"},"name":"ResearchStudyPhase","publisher":"HL7 (FHIR Project)","resourceType":"CodeSystem","status":"draft","text":{"div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><h2>ResearchStudyPhase</h2><div><p>Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.</p>\n</div><p>This code system http://terminology.hl7.org/CodeSystem/research-study-phase defines the following codes:</p><table class=\"codes\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style=\"white-space:nowrap\">n-a<a name=\"research-study-phase-n-a\"> </a></td><td>N/A</td><td>Trials without phases (for example, studies of devices or behavioral interventions).</td></tr><tr><td style=\"white-space:nowrap\">early-phase-1<a name=\"research-study-phase-early-phase-1\"> </a></td><td>Early Phase 1</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-1<a name=\"research-study-phase-phase-1\"> </a></td><td>Phase 1</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-1-phase-2<a name=\"research-study-phase-phase-1-phase-2\"> </a></td><td>Phase 1/Phase 2</td><td>Trials that are a combination of phases 1 and 2.</td></tr><tr><td style=\"white-space:nowrap\">phase-2<a name=\"research-study-phase-phase-2\"> </a></td><td>Phase 2</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-2-phase-3<a name=\"research-study-phase-phase-2-phase-3\"> </a></td><td>Phase 2/Phase 3</td><td>Trials that are a combination of phases 2 and 3.</td></tr><tr><td style=\"white-space:nowrap\">phase-3<a name=\"research-study-phase-phase-3\"> </a></td><td>Phase 3</td><td>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.</td></tr><tr><td style=\"white-space:nowrap\">phase-4<a name=\"research-study-phase-phase-4\"> </a></td><td>Phase 4</td><td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td></tr></table></div>","status":"generated"},"title":"ResearchStudyPhase","url":"http://terminology.hl7.org/CodeSystem/research-study-phase","valueSet":"http://hl7.org/fhir/ValueSet/research-study-phase","version":"4.0.1"}