Oversight in Clinical Development
Sponsor oversight is no longer a compliance checkbox. With ICH GCP E6(R3), it has become a continuous, risk-based, and documented responsibility that sits at the heart of trial quality — and one that many sponsors still struggle to apply consistently across trials, vendors, and functional areas.
At TriTiCon, we've developed a new online course that turns oversight from an abstract regulatory requirement into something you can actually plan, execute, and demonstrate.
Why oversight has changed
The shift from E6(R2) to E6(R3) is significant. Where earlier guidance asked sponsors to "ensure oversight" in fairly vague terms, the updated framework expects proactive governance, integrated with risk and quality management across the full trial lifecycle.
In practice, this means moving away from occasional monitoring and static documents — and toward continuous, risk-proportionate oversight that is tailored to each trial's complexity and supported by clear, demonstrable evidence during audits and inspections.
What the course covers
The course takes a hands-on approach, grounded in real sponsor workflows. It is organised into three chapters that build progressively from fundamentals to practical application:
- B03a — Definitions and key concepts. What oversight is and, just as importantly, what it is not. How it differs from QC, monitoring, and operational execution, and how it connects to Quality by Design and risk-based approaches.
- B03b — Oversight framework. A structured three-level model covering company, portfolio, and trial oversight — applicable across sourcing and outsourcing models.
- B03c — Oversight in practice. Concrete activities including approvals, KPIs and KQIs, spot checks, and QC-informed oversight, all applied in a risk-based way.
A three-level framework
At the core of the course is a practical framework that places oversight activities at the right level — reducing duplication, clarifying responsibilities, and making governance visible.
What you'll take away
After completing the course, you'll be able to:
- Apply a clear, working definition of oversight — and recognise activities that fall outside of it.
- Structure oversight across company, portfolio, and trial levels using a single coherent framework.
- Plan and document oversight activities that are risk-based, proportionate, and inspection-ready.
- Use approvals, KPIs/KQIs, and spot checks effectively — without drifting into operational execution.
Who it's for
The course is designed for sponsor-side professionals involved in planning, performing, or governing oversight of outsourced and delegated trial activities:
- Clinical Operations
- Data Management
- Vendor Management
- Quality Assurance
- Sponsor Oversight Leads
- Study Managers
A foundational understanding of clinical trials, regulatory frameworks, and key stakeholders is recommended. Beyond that, the only prerequisite is a willingness to learn and an open mind.
Start the course today
Build oversight that is risk-based, documented, and demonstrable.
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