Course Description

The ICH GCP E6 R3 update introduces significant advancements to clinical trial management, emphasizing flexibility, efficiency, and risk-based approaches. This revision refines key areas such as investigator responsibilities, quality management, and trial oversight to better align with the complexities of modern clinical research. This web seminar will provide an in-depth look at the changes brought about by the R3 update, focusing on their impact on clinical investigators, trial sites, and Sponsors-Investigators. Topics will include the expanded responsibilities of investigators, sponsors, and institutions regarding oversight, monitoring plans, risk assessments, and data integrity. Learners will also explore practical strategies for updating organizational SOPs, processes, and staff training to ensure compliance with the new guidelines. Actionable insights on how to implement the revised framework effectively, with a focus on maintaining high standards of trial quality and compliance will also be discussed.

Learning Objectives

• Identify key changes affecting investigator responsibilities and roles under the ICH GCP E6 R3 guidelines
• Explain how the revisions impact clinical trial sites and Sponsors-Investigators
• Evaluate potential solutions for adapting organizational SOPs, processes, procedures, and staff training to the updated guidelines
• Apply best practices for effective implementation of the ICH GCP E6 R3 guidelines in clinical trials
• Explore the broader implications of the ICH GCP E6 R3 updates for trial management and compliance

Who Should Attend

• Quality Assurance/Compliance Personnel
• Principal Investigators/Sub-Investigators
• Research Site Staff (Managers, CRCs, Data Managers/Data Entry)
• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, CRAs/Monitors (Centralized, On-site)

Instructor

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R. 

Click here for complete trainer biographies

Registration Fees

$835*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-030-L99-P. Released: 4/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.