@prefix fhir: . @prefix owl: . @prefix rdfs: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:NamingSystem ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "mdr"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "

Summary

Defining URLhttp://terminology.hl7.org/NamingSystem/mdr
Version3.0.0
NameMedDRA
TitleMedical Dictionary for Regulatory Activities
Statusactive
Definition

MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).#13;

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MedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level.

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PublisherMedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director

Identifiers

TypeValuePreferred
OID2.16.840.1.113883.6.163true
URIhttps://www.meddra.orgtrue
URIhttp://terminology.hl7.org/CodeSystem/mdrfalse
" ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/5.0/StructureDefinition/extension-NamingSystem.url"^^xsd:anyURI ] ; fhir:value [ fhir:v "http://terminology.hl7.org/NamingSystem/mdr"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/5.0/StructureDefinition/extension-NamingSystem.version"^^xsd:anyURI ] ; fhir:value [ fhir:v "3.0.0" ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/5.0/StructureDefinition/extension-NamingSystem.title"^^xsd:anyURI ] ; fhir:value [ fhir:v "Medical Dictionary for Regulatory Activities" ] ] ) ; # fhir:name [ fhir:v "MedDRA"] ; # fhir:status [ fhir:v "active"] ; # fhir:kind [ fhir:v "codesystem"] ; # fhir:date [ fhir:v "2023-06-15T00:00:00-04:00"^^xsd:dateTime] ; # fhir:publisher [ fhir:v "MedDRA Maintenance and Support Services Organization (MedDRA MSSO); Mr. Patrick Revelle; MSSO Director"] ; # fhir:contact ( [ fhir:name [ fhir:v "International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)" ] ; fhir:telecom ( [ fhir:system [ fhir:v "url" ] ; fhir:value [ fhir:v "https://www.ich.org/page/contact" ] ] ) ] ) ; # fhir:responsible [ fhir:v "MedDRA Maintenance and Support Services Organization (MedDRA MSSO)"] ; # fhir:description [ fhir:v "MedDRA is a multilingual standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance).#13;\n\r\nMedDRA is structured as a five level hierarchy. System Organ Classes (SOCs) are the broadest terms (e.g., Cardiac disorders, Investigations). The lowest level of the terminology is the Lowest Level Term (LLT) level."] ; # fhir:uniqueId ( [ fhir:type [ fhir:v "oid" ] ; fhir:value [ fhir:v "2.16.840.1.113883.6.163" ] ; fhir:preferred [ fhir:v "true"^^xsd:boolean ] ] [ fhir:type [ fhir:v "uri" ] ; fhir:value [ fhir:v "https://www.meddra.org" ] ; fhir:preferred [ fhir:v "true"^^xsd:boolean ] ] [ fhir:type [ fhir:v "uri" ] ; fhir:value [ fhir:v "http://terminology.hl7.org/CodeSystem/mdr" ] ; fhir:preferred [ fhir:v "false"^^xsd:boolean ] ] ) . # # -------------------------------------------------------------------------------------