The approvals process for non-CTIMPs

Non-CTIMPs include clinical trials that do not investigate the safety and efficacy of a medicinal product and other types of health and social care research.

The HRA, in collaboration with the 4 UK nations, has been considering how approval processes and timelines can better align with the changes brought in by the updated clinical trial regulations which come into effect on 28 April 2026.

The application, booking and REC meeting process and timeframe for non-CTIMPs will remain the same, however we’re providing more clarity on the timelines of the different stages of the approval process.

There will be no change to the process and timelines for Proportionate Review studies.

Initial application timeframes and process

Validation of applications

When a sponsor submits an application, the REC will carry out a check to confirm the submission is valid. We’ll aim to notify sponsors of the outcome of the validation check within 1 working day.

If we identify any issues preventing an application from being considered valid, we'll ask the sponsor to address these issues within 7 calendar days of the initial application submission.

If these issues cannot be resolved within 7 days, the submission will be invalid.

The sponsor will need to resubmit their application, making sure all issues have been addressed. All submissions will be confirmed as either valid or invalid within 7 calendar days of the submission.

For an application to be valid, it must include all required documents. PDF documents must be created directly from Microsoft Word or undergo Adobe Acrobat optical character recognition at the time of creation.

Initial review of trial applications

Once an application is valid, the REC will conduct an initial review. This includes the application being discussed at a full meeting of the REC.

For Proportionate Review studies the application will be discussed by a sub-committee of the REC.

The REC will complete the initial review as quickly as possible, and the outcome will be shared with the sponsor, and relevant individuals listed in the application, by email within a maximum of 30 calendar days of the application being confirmed as valid.

When booking an application to a REC, the sponsor will be offered a selection of possible REC meeting dates. If they choose the next available REC meeting, the start point for the 30 day period (for the REC review to be completed) will be when the application is confirmed as valid.

We expect applications to be submitted at least 14 calendar days before the REC meeting. If the sponsor does not choose the next available REC meeting, the 30 day period will begin 7 days before the chosen REC meeting, as long as the application is valid.

If a valid application has not been received, the application may be withdrawn, and the sponsor will need to resubmit for review at a different REC meeting.

Initial review outcomes

There are 4 possible outcomes from the initial REC review:

• favourable opinion
• favourable opinion subject to conditions
• provisional and request for further information (RFI)
• unfavourable

Requests for further information

If the REC is unable to issue a favourable opinion after the initial review, it will email the sponsor to request further information. The request will be sent as soon as it’s been confirmed by the REC. This means the sponsor will be able to receive and consider feedback from the REC as soon as it’s available.

From 28 April 2026, sponsors will have up to 60 calendar days from when the request is sent to respond. Sponsors can respond as early as they would like within these 60 days. The sponsor should not include any changes to documents or information that are not in response to the points raised when they respond to a request for further information.

If sponsors need longer than 60 days to respond, they can ask for an extension. Sponsors can do this by contacting the REC directly. In their request, the sponsor will need to explain why they need an extension and when they expect to respond.

If a request for an extension is not made (or agreed) and the sponsor does not submit a response within 60 calendar days, the REC will issue an unfavourable opinion.

Reviewing a response to a request for further information

If the REC sends a request for further information, an outcome will be given within 10 calendar days of the sponsor responding to the request. If the response is incomplete, or does not address the matters raised, the REC will contact the sponsor and ask them to submit a complete response to the request for further information.

The 10 day timeframe will not begin until a complete response to all issues raised by the REC is received. Once a complete response is received, the REC will review the response and provide the outcome as quickly as possible.

There are 3 possible outcomes from the REC reviewing a response to a request for further information. These are:

• favourable opinion
• favourable opinion subject to conditions
• unfavourable opinion

If the REC identifies ethical issues that mean an unfavourable opinion is given, the sponsor will still be able to appeal the decision.

They can do this by contacting us at appeals@hra.nhs.uk within 28 calendar days of receiving the outcome. In their appeal, the sponsor must explain why they disagree with the outcome.