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MedDRA (the Medical Dictionary for Regulatory Activities) is used to report adverse event data from clinical trials using standard terminology. The CTCAE (Common Terminology Criteria for Adverse Events) term can be mapped to the corresponding MedDRA term and code.
How it Works
Import the MedDRA variable group into your StudyTRAX project in the Encounter Variables section: Adverse Event (CTCAE mapping to MedDRA).xml
- When a CTCAE (Common Terminology Criteria for Adverse Events) Term is selected from the pick-list, the corresponding CTCAE SOC (System Organ Class) and CTCAE Code MedDRA term and code are automatically populated.
- Assign the MedDRA variable group to a non-fixed Adverse Event interval