Abstract
As a multifunctional, highly granular dictionary, the Medical Dictionary for Regulatory Activities (MedDRA) has the potential to provide standardized clinical, regulatory, and epidemiological information from individual safety reports. In order to maximize the value of such data, MedDRA users must establish a coding unit that can efficiently capture the maximum value from MedDRA and their data with minimum variability.This article will discuss the issues and solutions in establishing a high-volume, high-quality “regulatory authority grade” MedDRA coding and quality control group. PSI International is the lead organization that conceived, established, and continues to operate the Food and Drug Administration's (FDA's) Drug Safety Surveillance (DSS) unit. This group processes approximately 1000 adverse events per day and has now used MedDRA to codify over 300000 individual safety reports. The PSI team will also be the verification andquality assurance team reviewing industry's MedDRA coding in FDA's pilot p...
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