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.

The main REC (and the MHRA for CTIMPs) must be notified immediately and in any event within three days, in the form of a substantial amendment, that such measures have been taken and the reasons why.

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

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.
  

Copies of all safety information supplied to MHRA must also be emailed to the main Research Ethics Committee, accompanied by a CTIMPs Safety Report form.

Forms should not normally be used to submit reports covering more than one trial. However, 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.

The REC Manager will acknowledge receipt of all safety reports within 30 days by signing and returning a copy of the covering form. Reports sent without the covering form will not be acknowledged.

• 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 occurence)

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.

• 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