The MHRA has just released its specific annotations for the implementation of ICH GCP E6 (R3). This is a critical document because in the UK, international guidelines (ICH) do not automatically override national law.

For UK sponsors and sites, compliance means navigating the intersection of the 2004 Clinical Trials Regulations and the new R3 Principles.

Here are the 4 biggest practical implications you need to know:

1️⃣ The “Sponsor-Investigator” Responsibility Split

• ICH R3 says: Responsibilities can be flexible.
• UK Law says: The Sponsor retains ultimate liability. You can delegate tasks to vendors or CROs, but you cannot delegate the legal responsibility. The new annotations clarify that while R3 allows flexibility, UK regulations (Reg 3(12)) prevent you from “washing your hands” of oversight.

2️⃣ Safety Reporting (SUSARs)

• ICH R3 says: Report SUSARs to Ethics Committees (IRBs) and Investigators.
• UK Law says: 🛑 STOP. There is no legal requirement in the UK to flood investigators or Ethics Committees with individual SUSAR reports. Your obligation is to report to the MHRA. Don’t let R3 training create unnecessary administrative work for your sites.

3️⃣ Consent & “The Representative”

• ICH R3 says: Use a “Legally Acceptable Representative” (LAR) for those unable to consent.
• UK Law says: The definition of “Legal Representative” is strictly defined in Schedule 1, Part 1. It is not just “next of kin.” The UK specific annotations emphasize that you must follow the specific hierarchy defined in the 2004 Regulations (and the Mental Capacity Act where applicable).

4️⃣ Records & Archiving

• ICH R3 says: Retain records based on the “essentiality” of the document.
• UK Law says: The Trial Master File (TMF) must be retained for 25 years. The annotations confirm that while R3 introduces new concepts like “media-neutral” records, the statutory retention period in the UK remains explicitly strict under Reg 31A.

🚀 The Takeaway: Don’t just “adopt R3.” Adapt R3 to the UK context. The new MHRA annotations are your bridge between modern global standards and statutory UK law.

👉 Download the full MHRA Annotations here: UK-specific annotations to ICH E6(R3) – GOV.UK

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