Ongoing reporting

Safety updates and progress reports

Development Safety Update Reports (CTIMPs only)

Chief Investigators are required to submit a Development Safety Update Report (DSUR) to the MHRA and the REC, once a year throughout the clinical trial or on request.

The report should take into account all new available safety information received during the reporting period.

DSURs should be provided at yearly intervals. A data lock point should be set based on the date of the first CTA approval of the IMP or, for trials with marketed products, the date of the first marketing authorisation granted in the EU.

The DSUR must then be submitted no later than 60 calendar days from the data lock point. R&D require copies of all Development Safety Update Reports (DSURs) for our records. Guidance is available from R&D and on the MHRA website.

• Development Update Safety Reports (DSURs) - www.mhra.gov.uk
  

Annual progress reports (all clinical research)

A progress report should be submitted to the main REC annually on the anniversary of the date on which the favourable opinion was given. A copy must be sent to the R&D team (if applicable). Recruitment numbers are to be reported to the host organisation.

• OUH R&D Department - Contact us

Early end/temporary halt to the research

If the research is terminated prematurely or temporarily, it is the responsibility of the Chief Investigator (on behalf of the Sponsor) to notify the MHRA (if applicable) and REC within 15 days explaining the reasons for this. Termination of Clinical Trials should be reported using the End of Trial Form.

Please inform the R&D team promptly of any such suspension or early end. This applies to any research terminated early, for any reason, even if no participants have been recruited.

• OUH R&D Department - Contact us