OVERVIEW

The ICH E6 GCP update sets clear expectations that investigators will have oversight procedures in place that assure human subject protection, data integrity, and investigational product control. These updated expectations come in response to global audit findings related to investigator lack of oversight of delegated tasks over direct and indirect study site staff. It is essential that trial site culture include a proactive approach to trial management to support anticipation of problems and the ability to establish effective issues management.

The clinical trial space has not been successful in improving the overall performance of investigators in this regard.  Sponsors’ adoption of a risk-based monitoring approach will improve the oversight of the sponsor, while ensuring effective investigator oversight or management of critical issues for positive inspection findings and efficient process for trial management.

Join us for this 60 minute interactive webinar to identify the essential information you need to understand and implement effective and consistent investigator oversight in clinical trials, including which components of a site quality system and clinical trial execution plan must be in place.  You and your colleagues will be taken through a clinical trial case scenario applying an investigator oversight plan.

LEARNING OBJECTIVES

By attending this interactive live session, you will be able to:

• Define investigator oversight.
• Learn what ICH GCP E6 (R2) means for investigators and oversight.
• Identify essential site procedures for investigator oversight.
• Practice implementing an investigator oversight plan.