MedDRA
Medical abbreviation · Medical Research
| Stands for | Medical Dictionary for Regulatory Activities |
|---|---|
| Categories | Medical |
MedDRA stands for Medical Dictionary for Regulatory Activities, a medical research abbreviation.
Standardized international medical terminology used to code adverse events, medical history and indications in clinical trials, safety reports and regulatory submissions. Its five-level hierarchy runs from system organ class down to more than 80,000 lowest level terms.
Example: Investigator's "liver enzymes up" was coded in MedDRA as "Transaminases increased".
Usage notes
Developed under the ICH in the late 1990s and maintained by a maintenance and support services organization with updates twice a year. Regulators in the US, EU, Japan and other regions require it for electronic safety reporting. Pronounced "MED-druh".
Related abbreviations
More medical research abbreviations
- ITT – Intention-to-treat
- KM – Kaplan-Meier (estimator)
- LOE – Level of evidence
- LR – Likelihood ratio
- LTFU – Lost to follow-up
- MA – Meta-analysis
- MeSH – Medical Subject Headings
- MHRA – Medicines and Healthcare products Regulatory Agency
- NCT – National Clinical Trial (number)
- NICE – National Institute for Health and Care Excellence
- NME – New molecular entity
- NNH – Number needed to harm
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.