Are there really 12 principles in the new GCP E6 R3?

May 24, 2023 | Blog

As the revised guideline of πˆπ‚π‡ π„πŸ”(π‘πŸ‘) 𝐆𝐨𝐨𝐝 𝐂π₯𝐒𝐧𝐒𝐜𝐚π₯ 𝐏𝐫𝐚𝐜𝐭𝐒𝐜𝐞 (GCP) has been endorsed by ICH Expert Working Group (EWG) on 19th May 2023 and the draft document now published, there is a lot of talk about how the principles have changed. Initially, we were told there would be 12 principles in R3, and we saw these 12 principles in the initial draft principles document. However, on first glance of reading the full draft that has recently been released, I noticed there are now only 11 principles. On deeper inspection, I realised they have actually combined principles 1 and 2 from the draft originally released, making it now 11 principles.

Why was E6 R3 needed?

Having read the full document in great depth, I wanted to share my thoughts. I have also seen many posts talking about how R3 was brought in because of changes in technology over the years. Although increase in technology does get a mention, it is certainly not the main focus as many would have us believe.

The key reasons for need for R3 have been documented by ICH as:
– Developing a responsive GCP guideline
– Providing flexibility to acknowledge the diversity of trial designs, data sources, and the different contexts in which clinical trials can be conducted.

– Highlighting that GCP principles can be satisfied in a variety of ways.

They also have added an additional annex to the guidance.

Annex 1 – GCP for interventional clinical trials (principles related to the use of approved/unapproved drugs in a controlled setting with prospective allocation of treatment to participants and collection of trial data)

Annex 2 – additional considerations for non-traditional interventional clinical trials (principles as they relate to the use of non-traditional clinical trial designs such as pragmatic CTs, as well as trials that incorporate real world data sources).

The plan is also to align with the E8 guideline, as appropriate.
They plan to bridge the known gaps within the E6 guideline and other relevant ICH guidelines. The aim is to have a:
Clear and concise scope:
Expectations should be fit for purpose.
Focus on key concepts:
Quality by design and risk-based approach
Critical to quality factors, etc.

The GCP E6 R3 update

When the R2 addendum came out, we were faced with some very vague statements that could easily be open to interpretation. R3, as we have said, will now have 11 principles; each of those principles is now a main heading to many subprinciples, which in fact give us the detail of how we should be following each of the new principles. Some of the principles are the same as for R2, but many are completely new ones with new guidance that must be followed once E6 R3 is implemented.

As a Director of a company providing GCP training, I have been anxiously awaiting this full document to be released so I can work with my team to ensure my training course is updated and ready in time for those that need the update. Over recent days, we have done many a brainstorming session, pulling apart these principles to see where they really sit in the practicalities of how we perform clinical research. We could easily have just removed the 13 old principles and replaced them with the 11 new ones, but that would not do our learners justice. What they really need to know is what has changed but more importantly how the new principles need to be embedded in how we perform research.

So what are the 11 principles now?

1.Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with GCP and applicable regulatory requirement(s). Clinical trials should be designed and conducted in ways that ensure the rights, safety and well-being of participants.

2. Informed consent is an integral feature of the ethical conduct of a trial. Clinical trial participation should be voluntary and based on a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed.

3. Clinical trials should be subject to an independent review by an institutional review board/independent ethics committee (IRB/IEC).

4. Clinical trials should be scientifically sound for their intended purpose and based on robust and current scientific knowledge and approaches.

5. Clinical trials should be designed and conducted by qualified individuals.

6. Quality should be built into the scientific and operational design and conduct of clinical trials.

7. Clinical trial processes, measures and approaches should be implemented in a way that is proportionate to the risks to participants and to the importance of the data collected.

8. Clinical trials should be described in a clear, concise and operationally feasible protocol.

9. Clinical trials should generate reliable results.

10. Roles and responsibilities in clinical trials should be clear and documented appropriately.

11. Investigational products used in a clinical trial should be manufactured in accordance with applicable Good Manufacturing Practice (GMP) standards and be stored, shipped, handled and disposed of in accordance with the product specifications and the trial protocol.

How does the GCP E6 R3 update affect you?

Knowing what these principles are is great but it still doesn’t train you in GCP E6 R3. You need to have a greater understanding of the information contained in the subprinciples.

What makes our training different has always been that we don’t just recite a guidance document back to a learner but use our many years of research experience to really understand the guidance and then we put this experience into our courses so that whatever the level of understanding the learner has they gain knowledge and understanding from taking the course. So many times, I have been asked to take GCP online training as I have joined companies as a contractor and been faced with hours of just reading information that often doesn’t make sense or help me retain that information.

If you would like to enquire about booking in your company for an updated E6 R3 training day, then do get in touch. We are also in the process of updating our online GCP course to make sure you can get an up-to-date GCP E6 R3 certificate as soon as R3 is released. As a company, we aim to be one of the first to have our online GCP E6 R3 training updated and released, so keep an eye on our social media for the release date!

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