Quick Reference Guides and Updates for New Clinical Trials Regulations from 28 April 2026

As you are aware, the new UK Clinical Trials Regulations come into force at the end of April 2026.

Please read the below for an update on amendments (soon called modifications).

Please take a moment to read the information below - our SOPs will be updated accordingly.

The online Introduction to GCP Training is also being updated nationally to reflect the new regulations and should be finalised by the end of February. As soon as it’s available, we’ll let you know and ask all our staff involved in research delivery to plan time to complete the updated training. Sponsors will also begin asking for evidence of updated GCP, so we want everyone to be prepared as early as possible.

From 28 April 2026:

• All changes to an approved CTIMP will be called modifications, not amendments.
• Substantial amendments become Substantial Modifications.
• Non‑substantial amendments become Modifications of an Important Detail (small but regulated changes).
• Minor changes remain Minor Modifications.

The HRA confirmed that this terminology change applies to all studies under the new regulations: The approvals process for modifications (amendments) - Health Research Authority

The key reasons for this change are:

Before 28 April 2026

• Amendments are processed under old rules.
• MHRA had up to 35 days for substantial amendments.
• Process was slower and more fragmented.

From 28 April 2026

• Amendments become modifications.
• MHRA will use a new streamlined review process.
• The IRAS Modification Tool will be used instead of the Amendment Tool.
• Turnaround times are intended to be quicker and more consistent.

The old vs new rules: Amendments vs Modifications (from 28 April 2026) are summarised below as quick reference guide.

As part of the upcoming implementation of the new UK Clinical Trials Regulations at the end of April, we are sharing another key update that will impact how we deliver research across the Trust.

This update focuses on the new simplified consent provisions, which apply to specific lower‑risk CTIMPs.

Under the revised regulations, sponsors of eligible trials may use simplified arrangements for seeking and evidencing informed consent, replacing the default requirement for full written consent. These simplified arrangements are strictly limited to trials that:

• Use licensed medicines,
• Are given as part of routine NHS care, and
• Do not require any extra procedures, tests or treatments solely for research purposes.

Where simplified consent is used, REC approval is still required, and sponsors must provide clear justification in their protocol along with details of how participants will be informed and how consent will be recorded. Evidence of consent may be captured more flexibly (e.g., documentation in clinical notes rather than a signed consent form), but this must be agreed in advance.

SOPs and training materials will be updated to reflect this change.

For now, please familiarise yourselves with the changes summarised below:

• Not all studies qualify - this applies only to lower‑risk, authorised‑medicine trials delivered as part of routine care.
• Sponsors must tell us explicitly if simplified consent is being used.
• REC and MHRA remain responsible for approving its use.
• Staff will be trained in the agreed consent procedure for each study.
• Standard consent processes remain unchanged for all other studies.

Key links:

Simplified arrangements for consent in clinical trials - Health Research Authority

New report published on simplified arrangements for consent in clinical trials - Health Research Authority

Full MHRA & HRA guidance is still being finalised for this.

Under the current legislation, eligibility confirmation often has to be completed by a medically qualified investigator (e.g., doctor or dentist), unless the protocol explicitly allows another authorised clinical staff to do so.

Under the updated regulations, this changes. The definition of a qualified professional has been broadened: the term ‘authorised healthcare professional’ is being replaced with ‘UK registered healthcare professional’. This expanded definition includes a wider range of roles such as pharmacists, advanced practitioners, and other registered healthcare professionals, beyond the traditional medically‑qualified staff.

What this means for us:

• Under the new regulations, more roles can be delegated to confirm eligibility, including research nurses, advanced clinical practitioners, pharmacists, and other UK‑registered healthcare professionals (depending on protocol).
• Eligibility confirmation must still be:
  ✔ Delegated by the PI
  ✔ Performed by someone with appropriate registration, competence, and GCP + study‑specific training
• Clinical judgement elements must still be completed by someone professionally trained and competent to assess them.
• The PI retains overall responsibility for eligibility assessment.

The aim of this change is to make screening and set‑up more efficient and reduce dependency on medical availability, while continuing to ensure safe and appropriate decision‑making.

While the regulatory terminology change has been confirmed, MHRA has not yet published full, detailed guidance on exactly how eligibility confirmation will be operationalised under the new rules.

We therefore expect:

• Further clarification from MHRA on scope of delegation
• Additional examples of which roles may perform clinical eligibility checks
• Updates to sit alongside the new GCP guidance and modification guidance already published

As soon as MHRA publishes the full guidance, we will review it and update our SOPs, training materials, and delegation processes accordingly.

In the meantime, please continue to follow:

• The current expectations and GCP requirements
• Protocol‑specific instructions
• PI’s delegation