Establishing a Meddra Safety Surveillance Unit

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 program for electronic transfer of safety reports. As a part of its role in FDA's Drug Safety Surveillance Unit, PSI has had primary responsibility for: Developing operating procedures and training programs to manage staff transitions from COSTART and/or WHO-ART to MedDRA; establishing and evaluating coding principles for handling the increased granularity of MedDRA terms; and providing an outreach and familiarization program for the DSS MedDRA user community. This article will share PSI's extensive “hands on” experience with MedDRA in a real-world production environment. It will also identify key sources of information and regulatory guidance on MedDRA.