MedDRA (Medical Dictionary for Regulatory Activities) is an internationally recognized, highly standardized medical terminology system used by regulatory authorities and the biopharmaceutical industry. It serves to uniformly code data on adverse events (AEs), medical history, and other medical terms captured in clinical trials.
The hierarchical structure of MedDRA (with five levels, from System Organ Classes to the specific ‘Lowest Level Terms’) enables data to be analyzed and presented at various levels of aggregation. This is critical for pharmacovigilance, as it allows for consistent analysis of safety data across different studies and products and facilitates the detection of safety signals. For CROs, the correct and consistent coding of all medical terms according to MedDRA is a fundamental task of data management and pharmacovigilance.