Breakout 1: ICH E6(R3) and the Practical Reality of Vendor Accountability

It’s Complicated” Sponsors, CROs, and biotech partners face unique but overlapping responsibilities under R3. This session tackles the practicalities of vendor oversight across the study lifecycle and how to avoid the “finger-pointing trap.

Discussion Subtopics

• Mapping responsibilities across sponsor, CRO, and biotech: where the lines blur under R3.
• Oversight models that actually work in different study phases.
• Common pitfalls in delegation and accountability (e.g., safety reporting, data handling).
• How to document oversight without creating unmanageable bureaucracy.

Different Maps, Same Destination: Interpreting Oversight Under R3

ICH GCP E6(R3) brings welcome clarity to many parts of sponsor oversight, but in practice, it’s also creating new grey areas. As the guidance becomes more widely interpreted, we’re seeing a critical challenge emerge: different stakeholders understand accountability very differently.

How R3 Is Being Interpreted Differently

Let’s start with a key insight: R3 is being read through the lens of each stakeholder’s priorities.

• Sponsors often read it as an added compliance burden; they feel the pressure of new documentation requirements and oversight duties that stretch lean teams.
• CROs sometimes interpret R3 as a signal that sponsors want to delegate more, and may assume the sponsor is only there for strategic checkpoints.
• Investors and boards frequently believe that execution problems fall squarely on the CRO’s shoulders. If a milestone is missed, their first question is: “Why didn’t the vendor deliver?”

What this creates is a triangle of misunderstanding, each group holds different assumptions about who is accountable for what. This is where risk builds quietly.

When Responsibilities Blur

We’ve worked with sponsors who assumed CROs were handling SAE management governance, only to find out it was never included in scope.

We’ve also seen CROs escalate issues too late because they thought the sponsor was already monitoring that function.

These blurred lines happen when:

• Roles are only informally defined
• Oversight plans are vague or missing
• Sponsors rely on templates without revisiting actual risk
• Vendors make operational assumptions not backed by documentation

In an inspection setting, none of this holds up. You can’t rely on assumptions, you need evidence of who owned what and how it was tracked.

Oversight vs. Execution. Finding the Balance

One of the trickiest areas under R3 is distinguishing between oversight and execution. Here’s how to think about it:

• Execution is doing the work, data entry, lab processing, safety event follow-up
• Oversight is reviewing the quality and timeliness of that work, understanding the context, and intervening if it veers off track

The challenge is that many sponsors are lean. So where do you draw the line?

R3 doesn’t ask sponsors to re-do vendor work, but it does require that you can demonstrate how you knew the work was done correctly, what risks were tracked, and how those risks were managed. That means documenting:

• What you reviewed
• When and how you reviewed it
• What issues were escalated
• What your decision-making rationale was

This is where governance structures, regular check-ins, documented KPIs, escalation protocols, can serve as both control tools and evidence for inspection.

Avoiding Complexity While Gaining Clarity

Many sponsors hesitate to add more layers. That’s fair. But clarity doesn’t have to mean complexity.

Here are practical ways to align stakeholders early:

1. Create a clear accountability map. Use a simple table or matrix that shows who owns what across all major activities (regulatory, safety, data, drug supply). This should be co-developed with your CRO.
2. Document oversight approaches tied to risk. Not all tasks need equal oversight. Focus your documentation on areas where the consequences of failure are high, patient safety, data integrity, study continuity.
3. Set up a shared language for accountability. Terms like “manage,” “monitor,” and “own” are often used interchangeably. Agree upfront what these words mean within your trial context.
4. Communicate up the chain. Investors and boards should understand that CROs are partners, not insurers. Sponsors remain legally responsible for trial conduct, and oversight must be resourced accordingly.

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