With ICH E6 (R3) now implemented across most organizations, one question remains: is your setup inspection ready?
R3 isn’t just another update – it represents a mindset shift toward risk-proportionate oversight, evidence-based decision-making and protecting participants without adding unnecessary complexity. Many organizations, however, are still unsure whether their approach meets expectations.
From our own R3 journey, we’ve identified three quick wins that can help you stress-test your implementation and build post-rollout confidence.
- Update procedures to demonstrate risk-based thinking
Inspectors are not looking for more paperwork – they want to understand how you think and justify decisions. Standard operating procedures (SOPs) that take a one-size-fits-all approach often miss the key R3 expectation: every trial must be assessed on its own merits.
Show how you applied proportionality and why oversight was scaled the way it was. If reviewers cannot easily follow the rationale behind your process, compliance risk increases. SOPs should clearly demonstrate how decisions were risk-based, proportionate and aligned with the trial’s specific needs – not copied from another study or overloaded with unnecessary controls.
- Deliver role-specific training to make R3 practical
Generic GCP refreshers are no longer enough. R3 emphasizes that training should match the trial activities each person performs. It is about ensuring individuals have the competence and confidence to carry out their roles effectively.
For monitors, project managers, investigators or data teams, this means understanding how proportionality applies to their specific responsibilities – from monitoring plans to vendor oversight and deviation management.
Tailored training makes R3 practical. It helps teams apply the principles in their daily work, which is ultimately what inspectors want to see: consistent, informed decisions that demonstrate understanding of the guideline.
- Demonstrate oversight with evidence beyond contracts
This is where inspectors often look most closely. It is not enough to show that responsibilities were delegated or contracts were signed. The expectation under R3 is to provide evidence that oversight was active, risk-based and justified.
Ask whether you can clearly demonstrate:
- How and why oversight was focused on particular areas
- What risks were identified and how they were managed
- What follow-up actions were taken when vendors or sites raised concerns
If these answers are difficult to evidence, an internal or external audit can help reveal and close any gaps before an inspector does.
Why this matters
Post-implementation uncertainty is common. R3 represents a shift in thinking, not just new rules. The goal is to demonstrate that every decision is risk-based, proportionate and justified.
A focused health check – refining SOPs, tailoring training and strengthening oversight documentation – can make the difference between being compliant on paper and inspection-ready in practice.
How we can help
During our own R3 transition, we stayed closely connected to regulators and industry networks, participating in EMA and industry workshops, engaging with RQA and SQA, and speaking directly with those who shaped the guideline. These touchpoints helped us align our interpretation with both regulatory intent and industry best practice.
We now bring that experience to you through our post-implementation support services, including:
- Compliance checks
- Tailored training
- SOP development
- Audit preparation and support
Each designed to give you confidence that your ICH E6 (R3) implementation is both compliant and inspection ready.
Find out more – watch our latest webinar
In our latest webinar, “ICH E6 (R3): Are You Confident in Your Implementation?”, join our experts as they share lessons from our internal rollout, a real-world case study and insights into what inspectors are focusing on next.
Watch our on-demand webinar now.
You have implemented R3 – now make sure it stands up to inspection
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
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