GCP E6(R3): What Inspectors Will Test in Sponsor Oversight

Sponsor oversight under ICH-GCP E6(R3) places strengthened expectations on how sponsors direct, document, and demonstrate oversight of clinical trials, including activities performed by external suppliers. Inspection readiness therefore depends on more than having oversight responsibilities assigned. Sponsors need a clear strategy, supporting documentation, and contractual arrangements that show how oversight is planned and maintained in line with GCP expectations.

This webinar examines sponsor oversight requirements alongside common FDA and EMA inspection findings, connecting regulatory expectations with practical inspection preparation. Participants will consider what sponsor oversight means under E6(R3), what inspection readiness requires, and how oversight plans and records should support the sponsor’s approach. Particular attention is given to external suppliers, where responsibilities, contractual requirements, and the oversight strategy need to provide inspectors with clear evidence of how sponsor responsibilities are being addressed. The focus remains on translating strengthened oversight expectations into practical inspection preparation.

Understand What Inspectors Expect From Sponsor Oversight

Develop a clearer understanding of what sponsor oversight means under ICH-GCP E6(R3) and how inspectors may assess it. Reviewing FDA and EMA inspection findings helps clinical and quality teams connect the revised expectations with the oversight evidence they need to maintain when preparing for regulatory inspection.

Strengthen Oversight of External Suppliers

Strengthen the ability to establish an oversight strategy when clinical trial activities involve external suppliers. By connecting oversight plans, supporting documentation, and contractual requirements, sponsors can prepare clearer evidence of how responsibilities are managed and demonstrate that their oversight approach is aligned with inspector expectations.

Code: FDB1420