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Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials

Since the publication and global implementation of ICH GCP E6 R2, Institutions and Investigators are grappling with the appropriate and adequate approaches for qualifying external parties (e.g., testing facilities [clinical laboratories, radiology centers, medical specialists [ophthalmologist]) and implementing oversight of delegated trial-related duties, functions, activities and tasks. This session reviews the requirements and includes a panel discussion with experts in institutional research administration, operations and compliance, GCP compliance and a clinical investigator on how to implement the requirements, and how the sponsor/CRO Study Managers and Site Monitors are to monitor and manage the investigator/site.

Speaker:

  • Dr. Lionel Lewis, MD, Professor of Medicine/Pharmacology and Toxicology, Dartmouth Medical School

  • Erika Stevens, Principal, FTI Consulting

  • Liz Wool, RN, BSN, CCRA, CMT, President, Wool Consulting Group Inc.