Safety updates and progress reports
Requirements for Clinical Trials of Investigational Medicinal Products (CTIMPs) and other clinical research
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)
From the 1st August 2024 the Health Research Authority (HRA) removed the requirement to submit annual progress reports (APRs) to them for any research approved by an NHS Research Ethics Committee (REC) throughout the UK.
- Researchers still need to report to the HRA, NHS REC and RGEA anything that materially affects the ethics of an application
- Researchers still need to submit end of study notifications and final reports to the REC and RGEA
- If applicable, researchers should continue to submit to the Confidentiality Advisory Group (CAG) using the form on IRAS. This is because the legislation that CAG operates under requires the applicant to annually review how they are using confidential patient information. This annual review also allows for the public registers of approved applications to be updated and maintain an accurate record
Researchers must still continue to send APRs to RGEA (via rgea.reports@admin.ox.ac.uk ) to maintain Sponsor oversight. A new form will be created to meet this purpose, with further details forthcoming.
Further information on reporting requirements is available on the HRA's website.
Please bear with us as we update our processes, guidance and documents to align with this change, whilst ensuring we maintain robust Sponsor oversight.
