MedDRA
Pronunciation: med-DRA
Also written as: MedDRA — Medical Dictionary for Regulatory Activities
Standardized international medical terminology dictionary used for coding adverse events in clinical trials.
Full Definition
The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized international medical terminology developed under the auspices of the International Council for Harmonisation (ICH). It provides a single standardised international medical terminology that can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. In psychiatric research, MedDRA coding ensures consistent classification of adverse events across studies and regulatory jurisdictions. The terminology is hierarchically organized with System Organ Classes at the highest level, followed by High Level Group Terms, High Level Terms, Preferred Terms, and Lowest Level Terms.
Usage
Usage note: Always capitalize; specify version number when relevant for regulatory submissions.
In Context
- "All adverse events were coded using MedDRA version 25.0 at the Preferred Term level." — Clinical trial protocol
- "The investigator reported headache, which was coded as MedDRA PT 10019211." — Case report form