FHIR Cross-Version Extensions package for FHIR R4 from FHIR R5 - Version 0.0.1-snapshot-2. See the Directory of published versions
: ResearchStudy Phase Code System - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:CodeSystem ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "research-study-phase"] ; #
fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n <p>This code system \n <code>http://hl7.org/fhir/research-study-phase</code> defines the following codes:\n </p>\n <table class=\"codes\">\n <tr>\n <td style=\"white-space:nowrap\">\n <b>Code</b>\n </td>\n <td>\n <b>Display</b>\n </td>\n <td>\n <b>Definition</b>\n </td>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">n-a\n <a name=\"research-study-phase-n-a\"> </a>\n </td>\n <td>N/A</td>\n <td>Trials without phases (for example, studies of devices or behavioral interventions).</td>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">early-phase-1\n <a name=\"research-study-phase-early-phase-1\"> </a>\n </td>\n <td>Early Phase 1</td>\n <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>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-1\n <a name=\"research-study-phase-phase-1\"> </a>\n </td>\n <td>Phase 1</td>\n <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>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-1-phase-2\n <a name=\"research-study-phase-phase-1-phase-2\"> </a>\n </td>\n <td>Phase 1/Phase 2</td>\n <td>Trials that are a combination of phases 1 and 2.</td>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-2\n <a name=\"research-study-phase-phase-2\"> </a>\n </td>\n <td>Phase 2</td>\n <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>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-2-phase-3\n <a name=\"research-study-phase-phase-2-phase-3\"> </a>\n </td>\n <td>Phase 2/Phase 3</td>\n <td>Trials that are a combination of phases 2 and 3.</td>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-3\n <a name=\"research-study-phase-phase-3\"> </a>\n </td>\n <td>Phase 3</td>\n <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>\n </tr>\n <tr>\n <td style=\"white-space:nowrap\">phase-4\n <a name=\"research-study-phase-phase-4\"> </a>\n </td>\n <td>Phase 4</td>\n <td>Studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use.</td>\n </tr>\n </table>\n </div>"^^rdf:XMLLiteral
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "informative" ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
a fhir:integer ;
fhir:v 0 ]
] [
( fhir:extension [
fhir:url [ fhir:v "packageId"^^xsd:anyURI ] ;
fhir:value [
a fhir:id ;
fhir:v "hl7.fhir.uv.xver-r5.r4" ] ] [
fhir:url [ fhir:v "version"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "0.0.1-snapshot-2" ] ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/package-source"^^xsd:anyURI ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [
a fhir:code ;
fhir:v "brr" ]
] ) ; #
fhir:url [ fhir:v "http://hl7.org/fhir/research-study-phase"^^xsd:anyURI] ; #
fhir:version [ fhir:v "5.0.0"] ; #
fhir:name [ fhir:v "ResearchStudyPhase"] ; #
fhir:title [ fhir:v "ResearchStudy Phase Code System"] ; #
fhir:status [ fhir:v "active"] ; #
fhir:experimental [ fhir:v false] ; #
fhir:date [ fhir:v "2022-05-15T15:55:11.085+10:00"^^xsd:dateTime] ; #
fhir:publisher [ fhir:v "Biomedical Research and Regulation"] ; #
fhir:contact ( [
fhir:name [ fhir:v "Biomedical Research and Regulation" ] ;
( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ] ] )
] ) ; #
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:jurisdiction ( [
( fhir:coding [
fhir:system [ fhir:v "http://unstats.un.org/unsd/methods/m49/m49.htm"^^xsd:anyURI ] ;
fhir:code [ fhir:v "001" ] ;
fhir:display [ fhir:v "World" ] ] )
] ) ; #
fhir:caseSensitive [ fhir:v true] ; #
fhir:valueSet [
fhir:v "http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/ValueSet/research-study-phase|4.0.1>
] ; #
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." ]
] ) . #
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