Safety reporting

A sponsor or investigator may take appropriate urgent safety measures in order to protect research participants against any immediate hazard to their health or safety, without prior authorisation from a regulatory body.

For studies not submitted via combined review

The research ethics committee (REC) must be notified by email within three days. The notice should set out that such measures have been taken and the reasons why. Where an urgent safety measure (USM) requires an amendment to study documents, this should be submitted as a substantial amendment as soon as possible. The amendment should be marked as being in response to urgent safety measures and a copy of the USM notification should be submitted with the amendment.

Copies of the information should be provided to the REC that approved the study using the appropriate REC safety reporting cover sheet (see below).

For CTIMPs submitted via combined review

An urgent safety measure (USM) notification should be submitted in IRAS. No additional notification is required to the REC. Where an urgent safety measure (USM) requires an amendment to study documents, this should be submitted as a substantial amendment as soon as possible. The amendment should be marked as being in response to urgent safety measures.

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 one trial, though this may be permitted by the REC where two 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, including a signed copy of the covering letter, 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 one 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.

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 in addition to the information provided through the annual progress report.

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) then you should check with them about their requirements for safety reporting.

More detailed information on safety reporting can be found in section 10 of the Standard Operating Procedures