Progress and Safety Reporting

Resource page

 

Safety reports for CTIMPs

Safety and progress reports (CTIMPs)  procedural table [pdf, 39.5KB]

CTIMP safety report resource page

 

Safety reports for other research

Safety and progress reports (other research) procedural table [pdf, 33KB)

Non- CTIMP safety report to REC (doc, 48KB)

This form should accompany reports of SUSARs in the UK, annual safety reports, and any other reports submitted (for example, reports of data monitoring committees).

All enclosures should be listed and referenced on the form. The form should be sent to the REC office by email together with all enclosures.  Alternatively, extensive reports may be provided on CD.  Reports should not be sent as paper copy.  There is no need for forms to be signed.

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 of the main REC 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.

You can find more information about safety reports in section 10 of the Standard Operating Procedures.

 

Progress reports:

Please refer to the progress report resource page.