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Post-ICH GCP E6 R2: Institution/Investigator Qualification and Oversight of External Parties in Clinical Trials
Liz Wool, RN, BSN, CCRA, CMT, President, Wool Consulting Group Inc.
Program Description: 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.
Erika Stevens, MA, Sr. Managing Director, FTI Consulting
Lionel Lewis, Professor of Medicine/Pharmacology & Toxicology, The Geisel School of Medicine at Dartmouth & Dartmouth-Hitchcock Medical Center
Upon completion of this program, attendees should be able to:
- Evaluate external parties’ responsibilities and contributions to the study in order to accurately design and implement investigator supervision and oversight of the work performed and data generated for the trial.
- Discuss the Investigator/Institution ICH GCP E6 R2 requirements for the qualification and oversight of an individual/party (external parties).
- Analyze healthcare organization qualification standards and approaches for both a facility and medical / practitioners to leverage in clinical research for the ICH GCP E6 R2 requirements.
Clinical Research Professionals (Investigators, CRCs, CRAs, Regulatory, etc)
$0 (free for all to attend) Contact hours:
2.0 Contact hours have been approved for through ACRP. Membership is not required for online registration of contact hours. To receive contact hours:
Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then "My Courses” to complete the evaluation no later than 30 days following the event and obtain the online certificate. Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
No refunds Level: