Safety updates and progress reports

Development safety update reports (CTIMPs only)

Chief investigators must submit a development safety update report to the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (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.

A data lock point should be set based on the date of the first Clinical Trial Agreement (CTA) approval of the Investigational Medicinal Product (IMP) or, for trials with marketed products, the date of the first marketing authorisation granted in the EU. 

The DSUR must be submitted no later than 60 calendar days from the data lock point.

The Research Governance, Ethics & Assurance Team require copies of all DSURs. Guidance is available from the Research Governance, Ethics & Assurance Team, the MHRA and HRA.

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 Research Governance, Ethics & Assurance Team and the relevant NHS Research and Development (R&D) office (if applicable).

Recruitment numbers must be reported to the host organisation.