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.
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.