standards > terminology artifact > DOI:10.25504/FAIRsharing.ad3137


ready Medical Dictionary for Regulatory Activities Terminology

Abbreviation: MedDRA


General Information
MedDRA is a multilingual terminology allowing most users to operate in their native languages. MedDRA can be used to analyse individual medical events (e.g., “Influenza”) or issues involving a system, organ or etiology (e.g., infections) using its hierarchical structure. MedDRA can be used for signal detection and monitoring of clinical syndromes whose symptoms encompass numerous systems or organs using its multi-axial hierarchy or through the special feature of Standardised MedDRA Queries. The ability to communicate adverse event data is another strength of MedDRA and has lead to MedDRA being an integral part of the ICH e-submission standards: eCTD (ICH M8) and ICSRs (ICH E2B).


This record replaces or incorporates the following deprecated resources:

Homepage http://www.meddra.org/

Countries that developed this resource United States

Created in 1993

Taxonomic range

Knowledge Domains 




How to cite this record FAIRsharing.org: MedDRA; Medical Dictionary for Regulatory Activities Terminology; DOI: https://doi.org/10.25504/FAIRsharing.ad3137; Last edited: June 27, 2019, 2 p.m.; Last accessed: Dec 01 2020 9:12 p.m.


This record is maintained by MedDRAMSSO

Record updated: June 27, 2019, 2 p.m. by The FAIRsharing Team.

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In Collections
RDA Covid-19 WG Resources
eTRIKS Standards Starter Pack



Tools
Standardised MedDRA Queries http://www.meddra.org/how-to-use/tools/smqs
MedDRA Version Analysis Tool https://tools.meddra.org/mvat/

Schemas

No XSD schemas defined


Access / Retrieve Data

Conditions of Use

Applies to: Data use

Data Access

browse https://tools.meddra.org/wbb/



Publications

The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

Yokotsuka M,Aoyama M,Kubota K
Int J Med Inform 2000

View Paper (PubMed)

The medical dictionary for regulatory activities (MedDRA).

Brown EG,Wood L,Wood S
Drug Saf 1999

View Paper (PubMed) View Publication

MEDDRA Ontology Display

View in BioPortal.


Disclaimer: This widget assumes the availability of the ontology resources in the NCBO BioPortal.


Related Standards

Reporting Guidelines

No guidelines defined

Terminology Artifacts

No semantic standards defined

Models and Formats

Identifier Schemas

No identifier schema standards defined

Metrics

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