Purposes of using MedDRA

To code (classify) ADR/AEs, history, indication, investigations, procedures, etc.Verbatim/reported information is linked to a MedDRA Lowest Level Term (LLT),LLTs have a parent concept Preferred Term (PT) Grouping terms and System Organ Classes (SOCs) logically group concepts for later retrieval and analysis.Used for coding, assessment, and reporting of safety data for both marketed products and clinical studies.

Purpose:

• To aggregate reported terms in medically meaningful groupings for the purpose of reviewing and/or analyzing safety data
• To facilitate identification of common data sets for evaluation of clinical and safety information
• To facilitate consistent retrieval of specific cases or medical conditions from a database
• To improve consistency in comparing and understanding “safety signals” and aggregated clinical data
• To facilitate electronic data interchange of clinical safety information
• To report adverse reaction/adverse event (ADR/AE)2 terms via individual case safety reports
• To include ADR/AEs in tables, analyses, and line listings for reports
• To identify frequency of medically similar ADR/AEs
• To capture and present product indications, investigations, medical history, and social history data