Webinar
Beyond the Signature: What ICH GCP R3 Really Means for Site and Sponsor Oversight
May 30 | Friday
18.00 – 19.00 CEST
Zoom | онлайн
Register now ICH GCP E6(R3) Training
Why This Topic Matters
We’ve operated for years under the assumption that sponsor oversight could be covered by a contract or an SOP. But ICH GCP E6(R3) makes it clear: that’s not enough anymore.
Oversight now has its own dedicated section- 3.9- because it’s not just an administrative function. It’s at the heart of ethical, reliable clinical research.
As an auditor, I’ve seen how easily oversight gets reduced to paperwork. But that’s not what protects participants. That’s not what ensures valid data. This session is about moving from formality to accountability- and showing what that transition actually looks like.
Maxim Bunimovich
CEO, Founder & Auditor, MD, MRQA, SQA
Spain
What We’ll Cover (60 minutes)
May 30
Introduction: Oversight is Changing (5 mins)
Introduction: Oversight is Changing (5 mins)
We’ll open with a reality check: GCP compliance has never just been about policies—it’s about how people work. E6(R3) calls for a cultural shift: toward thoughtful, role-based, and risk-aware oversight.
Sponsor Oversight in R3 – What’s Really New
(15 mins)
Sponsor Oversight in R3 – What’s Really New
(15 mins)
Sponsor oversight now gets its own section for a reason. It reframes our understanding of responsibility—from “did we document it?” to “did we ensure it was done, done right, and done with awareness of its impact?”
I won’t go line by line here—but we’ll touch on some of the critical expectations:
  • Defining what’s important vs. what’s procedural
  • Managing protocol deviations with intent
  • Re-thinking how we assess risk and proportionality
  • Strengthening—not just writing—oversight mechanisms
And yes—this includes how we work with vendors, investigators, and trial committees. We’ll explore this live together.
Audit & Inspection Lessons from R2
(20 mins)
Audit & Inspection Lessons from R2
(20 mins)
This section brings the theory to life. We’ll walk through audit findings I’ve personally seen over the years and unpack them in light of R3.
Under R2, we often saw:
  • Delegation without appropriate training
  • Oversight plans with no evidence of follow-up
  • Protocol deviations treated equally—no triage, no impact assessment
Under R3, we now need:
  • Targeted training based on delegated roles
  • Documented decisions and escalation pathways
  • Criteria for identifying Important Protocol Deviations—not just logging everything the same way
You’ll see how existing pain points are being directly addressed in R3—and what “good” looks like moving forward.
Practical Oversight That Works
(15 mins)
Practical Oversight That Works
(15 mins)
Here we’ll shift from critique to construction.
We’ll discuss tools and strategies you can use now, even without additional headcount or systems:
  • Simple templates for oversight decision logs
  • Mapping delegated tasks to specific training
  • Using audits as checkpoints for readiness, not fear
We’ll also talk about common implementation pitfalls—because good intentions alone won’t meet R3 expectations.
Q&A and Reflection (10 mins)
Q&A and Reflection (10 mins)
We’ll close by inviting participants to reflect:
  • Where is your oversight process clear on paper, but shaky in practice?
  • What’s one area where your team could move from “compliant” to “confident”?
Speaker

What You’ll Gain:
  • Clear understanding of the new R3 expectations for sponsor and site oversight—beyond signatures and SOPs
  • Clarity on Section 3.9 and why it reframes oversight as an active, ethical responsibility
  • Insights from real audit findings that reveal common gaps—and how to fix them under R3
  • Practical tools to strengthen oversight today, without waiting for new systems or headcount
  • Concrete strategies for risk-based delegation, vendor collaboration, and deviation triage
  • A chance to ask questions and get direct answers from an experienced GCP auditor
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