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University of Michigan *

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400

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Medicine

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Apr 29, 2024

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pptx

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8

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Understanding MedDRA MedDRA (Medical Dictionary for Regulatory Activities) is a comprehensive medical terminology used worldwide to classify and report adverse events and other medical information related to the use of medical products. aa by anan baban
History and Development of MedDRA 1 1994 MedDRA was first developed by the International Conference on Harmonisation (ICH) to standardize the reporting of adverse events in clinical trials. 2 1999 MedDRA version 2.0 was released, expanding the terminology to cover a wider range of medical conditions and events. 3 2020 The latest version, MedDRA 23.0, continues to be updated and maintained by the MedDRA Maintenance and Support Services Organization (MSSO).
MedDRA Structure and Terminology Hierarchical Structure MedDRA has a five-level hierarchical structure, with System Organ Classes at the top and Lower Level Terms at the most granular level. Terminology MedDRA contains over 70,000 terms that cover a wide range of medical conditions, symptoms, diagnoses, therapeutic indications, and more. Coding System Each term in MedDRA is assigned a unique code, allowing for precise and standardized coding of medical information.
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