Medical Writing Regulatory Writing Basics Adverse event reporting: A brief overview of MedDRA
mew-150pxjpg

Volume 23, Issue 2 - Regulatory Writing Basics

Adverse event reporting: A brief overview of MedDRA

Abstract

Since its inception 20 years ago, the Medical Dictionary for Regulatory Activities (MedDRA) has become the lingua franca of safety reporting in a regulatory context. The standardised reporting across different regulatory regions and languages is a major strength of MedDRA. The detail offered by the large number of terms may, in principle, be considered an advantage too, but increased granularity is not without its problems. Awareness of the potential issues with MedDRA should help medical writers provide clear, transparent safety reporting.

Download the full article

References

  1. Wood KL. The medical dictionary for drug regulatory affairs (MEDDRA) project. Pharmacoepidemiol Drug Saf 1994;3(1):7–13.
  2. Mozzicato P. MedDRA: an overview of the Medical Dictionary for Regulatory Activities. Pharm Med 2009;23(2):65–75.
  3. Brown E, Douglas S. Tabulation and analysis of pharmacovigilance data using the medical dictionary for regulatory activities. Pharmacoepidemiol Drug Saf 2000;9(6):479–89.
  4. MedDRA. MedDRA® data retrieval and presentation: points to consider ICH – Endorsed Guide for MedDRA Users on Data Output. 2014.
  5. Schroll JB, Maund E, Gøtzsche PC. Challenges in coding adverse events in clinical trials: a systematic review. PLoS ONE 2012;7(7):e41174.
  6. Tonéatti C, Saïdi Y, Meiffrédy V, Tangre P, Harel M, Eliette V, et al. Experience using MedDRA for global events coding in HIV clinical trials. Contemp Clin Trials 2006;27(1):13–22.
  7. Kondro W, Sibbald B. Drug company experts advised staff to withhold data about SSRI use in children. CMAJ 2004;170(5):783.
  8. Ben Goldacre. Bad Pharma: how medicine is broken, and how we can fix it. London, UK: Fourth Estate; 2013.

Search

Articles

Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One examining the fates of retracted articles
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Feature Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief:

Co-Editor:

Managing Editor

  • Victoria White (Tampa, Florida, USA)
show all +

Associate Editors:

Section Editors:

Ad-hoc Editors:

  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

Editor Emeritus: