The procedures for safety reporting will vary depending on your type of study.
For clinical trials of investigational medicinal products (CTIMPs), the way in which you submit some of the reports may differ depending on whether the study was submitted through Combined Review or not.
From 28 April 2026, the safety reporting requirements for CTIMPs change in line with the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. The new requirements apply to all CTIMPs whether they were submitted before or from this date.
The sponsor of a clinical trial approved before this date may elect to have the trial temporarily continue in compliance with the previous legislation's safety reporting requirements.
Requests for this will need to be made to the Medicines and Healthcare products Regulatory Agency (MHRA).
Please see the MHRA's guidance for transitional arrangements for the new clinical trials regulations which includes information on this and how you can request it.
Suspected unexpected serious adverse reactions (SUSARs) and annual safety reports
Before 28 April 2026, suspected unexpected serious adverse reactions (SUSARs) and annual safety reports for CTIMPs that were not submitted through Combined Review were sent to both the MHRA and Research Ethics Committee (REC). SUSARs and annual safety reports for CTIMPs submitted through Combined Review were only reported to the MHRA.
From 28 April 2026, SUSARs and annual safety reports for all CTIMPs (whether they were submitted via Combined Review or not) are only to be reported to the MHRA. If any ethical issues are identified by the MHRA when they receive these reports, they will liaise with the REC directly.
For further information on how to submit these to the MHRA, and the timeframes for doing so, read the MHRA's guidance.
Urgent safety measures (USMs)
From 28 April 2026, the period a sponsor has to give written notice to the REC and MHRA for a USM they take is extended from 3 calendar days to 7 calendar days.
The process which sponsors follow to give written notice to a REC of a USM remains the same. This means that if any of the trials relating to the USM are submitted through Combined Review, the sponsor should submit the notice of the USM through the Integrated Research Application System (IRAS). However, if all the trials relevant to the USM are not submitted through Combined Review, the sponsor should notify the REC by email. In all cases the sponsor should make sure the notification clearly explains that measures have been taken and the reasons why.
If a USM requires a change to study documents, this should be submitted as a modification as soon as possible. The modification submission should be identified as being in response to a USM and should include a copy of the USM notification.
Please see the MHRA guidance on safety reporting for information on how to notify the MHRA of a USM.
Safety reporting for CTIMPs
You must report the following to the MHRA. (These links will take you to the relevant page on the MHRA website:)
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Development Safety Update Reports (DSURs)
- Any significant findings and recommendations of an independent data monitoring committee or equivalent body established for the trial
For CTIMPs not submitted via combined review
The REC should be notified by using the CTIMPs Safety Report form, which is a standard cover sheet. A single CTIMP Safety Report form may be used for the submission of multiple safety reports for the same trial. The CTIMP Safety Report form should not normally cover more than 1 trial, though this may be permitted by the REC where 2 trials are very closely connected, for example a main study and an extension study with the same treatment regime.
You’ll receive an acknowledgment receipt of all safety reports, by email within 30 days. Reports sent without the CTIMP safety report form cover sheet will not be acknowledged.
For CTIMPs submitted via Combined Review
Development safety update reports (DSURs) should be submitted in IRAS where at least 1 of the trials was submitted through Combined Review.
Suspected unexpected serious adverse reactions (SUSARs) should be submitted to the MHRA as per the guidance on the MHRA website. You do not need to submit a separate notification to the REC. The MHRA will liaise with the REC if deemed appropriate.
See the safety and progress reports (CTIMPs) procedural table.
Safety reporting for non-CTIMP studies
For all other studies, including clinical investigations of medical devices, only reports of serious adverse events (SAEs) that are:
- related to the study (ie they resulted from administration of any of the research procedures) and
- unexpected (ie not listed in the protocol as an expected occurrence)
Should be emailed to the REC using the Non-CTIMP safety report to REC form.
These should be sent within 15 days of the chief investigator becoming aware of the event. Reports of SAEs in double-blind trials should be unblinded. There is no requirement for annual safety reports.
See the safety and progress reports (other research) procedural table.
The information in this section applies to HRA’s expectations for safety reporting. If your research has approval(s) from other organisation(s), you should check with them about their requirements for safety reporting.
More detailed information on safety reporting can be found in the Standard Operating Procedures.