---
type: "codesystem"
title: "ResearchStudy Phase Code System"
codesystem: "research-study-phase"
---
# ResearchStudy Phase Code System

- **Official URL**: http://hl7.org/fhir/research-study-phase
- **Version**: 6.0.0
- **Status**: draft
- **Name**: ResearchStudyPhase
- **Title**: ResearchStudy Phase Code System
- **Publisher**: HL7 (FHIR Project)
- **Description**: Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
- **Case Sensitive**: true
- **Content**: complete

## Concepts

| Code | Display | Definition |
| --- | --- | --- |
| n-a | N/A | Trials without phases (for example, studies of devices or behavioral interventions). |
| early-phase-1 | Early Phase 1 | 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. |
| phase-1 | Phase 1 | 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. |
| phase-1-phase-2 | Phase 1/Phase 2 | Trials that are a combination of phases 1 and 2. |
| phase-2 | Phase 2 | 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. |
| phase-2-phase-3 | Phase 2/Phase 3 | Trials that are a combination of phases 2 and 3. |
| phase-3 | Phase 3 | 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. |
| phase-4 | Phase 4 | Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use. |

## CodeSystem XML



```xml
<?xml version="1.0" encoding="UTF-8"?>
<CodeSystem	xmlns="http://hl7.org/fhir">
	<id value="research-study-phase"/>
	<meta>
		<lastUpdated value="2022-05-15T16:55:11.085+11:00"/>
		
	</meta>
	<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
		<valueCode value="brr"/>
	</extension>
	<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
		<valueCode value="normative"/>
	</extension>
	<extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
		<valueInteger value="0"/>
	</extension>
	<url value="http://hl7.org/fhir/research-study-phase"/>
	<version value="6.0.0"/>
	<name value="ResearchStudyPhase"/>
	<title value="ResearchStudy Phase Code System"/>
	<status value="draft"/>
	<experimental value="false"/>
	<date value="2022-05-15T16:55:11.085+11:00"/>
	<publisher value="HL7 (FHIR Project)"/>
	<contact>
		<telecom>
			<system value="url"/>
			<value value="http://hl7.org/fhir"/>
		</telecom>
		<telecom>
			<system value="email"/>
			<value value="fhir@lists.hl7.org"/>
		</telecom>
	</contact>
	<description value="Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation."/>
	<caseSensitive value="true"/>
	<valueSet value="http://hl7.org/fhir/ValueSet/research-study-phase"/>
	<content value="complete"/>
	<concept>
		<code value="n-a"/>
		<display value="N/A"/>
		<definition value="Trials without phases (for example, studies of devices or behavioral interventions)."/>
	</concept>
	<concept>
		<code value="early-phase-1"/>
		<display value="Early Phase 1"/>
		<definition value="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."/>
	</concept>
	<concept>
		<code value="phase-1"/>
		<display value="Phase 1"/>
		<definition value="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."/>
	</concept>
	<concept>
		<code value="phase-1-phase-2"/>
		<display value="Phase 1/Phase 2"/>
		<definition value="Trials that are a combination of phases 1 and 2."/>
	</concept>
	<concept>
		<code value="phase-2"/>
		<display value="Phase 2"/>
		<definition value="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."/>
	</concept>
	<concept>
		<code value="phase-2-phase-3"/>
		<display value="Phase 2/Phase 3"/>
		<definition value="Trials that are a combination of phases 2 and 3."/>
	</concept>
	<concept>
		<code value="phase-3"/>
		<display value="Phase 3"/>
		<definition value="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."/>
	</concept>
	<concept>
		<code value="phase-4"/>
		<display value="Phase 4"/>
		<definition value="Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use."/>
	</concept>
</CodeSystem>
```