Pulse

MedDRA now available at EVMS

By

Brickell Library

EVMS has an institutional license to MedDRA (Medical Dictionary for Regulatory Activities), a clinically validated international medical terminology used by regulatory authorities, including the FDA. It is also used by industry, academics, health professionals and other organizations to communicate medical information. 

MedDRA is a standardized dictionary of terms used to describe adverse events of drugs and therapeutic biologic products in animal and clinical trials. Medical terms are linked to capture logical relationships, making it possible to create meaningful summaries and conduct analyses. 

Register for a training session for MedDRA on Thursday, Aug. 4, at 2 p.m.  The EVMS institutional username (ID number) and password are available through myPortal on the top of the Research page. Per EVMS' agreement with MedDRA, these credentials may not be shared with non-EVMS associates.  

MedDRA includes standardized terms for:

  • symptoms, signs, diseases, syndromes and diagnoses
  • medical device malfunctions
  • medication errors
  • medical, social and family history information
  • sites (e.g. application, implant and injection sites)
  • medical and surgical procedures
  • approved uses for medications and medical devices
  • types of investigations (e.g. liver function analyses, metabolism tests).

MedDRA terminology incorporates terminology from the following agencies:

  • Medicines and Healthcare products Regulatory Agency (MHRA)
  • World Health Organization Adverse Reaction Terminology (WHO-ART)
  • International Classification of Diseases (ICD)
  • International Classification of Diseases and Clinical Modification (ICD-CM)
  • Coding Symbols for a Thesaurus of Adverse Reaction Terms (COSTART)
  • Japanese Adverse Reaction Terminology (J-ART).

(adapted from https://www.tga.gov.au/medical-dictionary-regulatory-activities-meddra)

Additional information about MedDRA is available at the following sites:

https://www.meddra.org/

https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/MDR/index.html

Additional information about other Clinical Research resources at EVMS is available at the following site:

https://www.evms.edu/research/research_administration/evms_research/metro/research_resources/