Biography
Biography: Peggy J Berry
Abstract
Good clinical practices continue to be a major focus of Regulatory Agencies to ensure the consistency and reliability of data and the protection of human subjects. This presentation will review specific GCP requirements for sponsors, investigators, and IRBs. Providing practical guidance and successful implementation strategies, as well as oversight strategies for vendors, contractors, and clincal study sites. We will also examine evolving practices in GCPs, including electronic case report forms, patient diaries, and consent forms, risk-based monitoring, and effective project management. Examples and case studies will provide scenario-based learning for monitors, auditors and other study management personnel. Suggestions for effectively training and managing monitors, investigators and study staff will also be provided.