Course Description

ICH GCP E6 R2 is the first revision in 20 years and includes changes that are prescriptive, detailed and more consistent with the rapid, ongoing changes in the complexity and rising cost of clinical trials. Understanding these changes and how they impact your organization is the first critical step towards implementation. This web seminar will describe the addendums in a step-by-step process and provide a parallel discussion of how the revised guideline can improve efficient approaches to trial management. Discussion topics include: The effects on sponsors/CROs; clinical trial design; trial conduct and monitoring; and oversight/documentation and reporting. Practical information on how to incorporate the revisions to better manage human subject projection, understand the new definitions for monitoring plan, certified copy, and computerized systems, explore changed responsibilities to ensure data quality and integrity will also be provided.

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Learning Objectives

• Identify three changes that impact sponsors/CROs and individual roles
• Explain the impact of the revisions on clinical trial conduct and organizational practices
• Discuss opportunities for implementing the revised guideline

Who Should Attend

• Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
• Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site)

Instructor

Mary Mills, R.N., C.C.R.A.

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