The revision (R2 Addendum) of ICH E6 Guidelines was in response to the increase in scale, complexity, and cost of clinical trials. The new revision focuses on updating and clarifying standards for sponsor and investigator oversight, quality data characteristics, electronic records and essential documentation. A foundational understanding of these topics is critical to running successful trials. Therefore, it is important to train your team on the revisions and have an action plan to implement improvements with change control in mind.
This session will provide you and your colleagues training on the major updates and how they specifically impact clinical researchers. Within each section covered, the training includes use cases to support application of the new requirements and suggestions for action planning.
This 60-minute course will provide you with the essential information you need in regard to the changes in ICH GCP, and application strategies regarding the new responsibilities and best practices. By attending this interactive live session, you will be able to:
- Apply critical thinking techniques for effective implementation of the new ICH E6 guidelines
- Learn how the new guidances affect your role
- Discuss challenges and opportunities in implementing the new guidances