Skip to content
left end
left end
right end

Annual Reporting

Annual Progress Reports

Annual progress reports should be submitted annually following a favourable opinion from an NHS Research Ethics Committee (REC) and thereafter until the end of the study. The Chief Investigator (CI) should submit progress reports to the REC, which should include information on the safety of participants.

There are separate forms for studies involving Investigational Medicinal Products (IMPs) and the forms can be found on the HRA website:

http://www.hra.nhs.uk/resources/during-and-after-your-study/nhs-rec-annual-progress-report-forms/

For studies where UH Bristol are acting as Sponsor, a copy of the completed progress report should also be sent to the Research & Innovation Department (R&I), preferably as a pdf via email to research@uhbristol.nhs.uk.

Annual Safety Reports

For Clinical Trials of Investigational Medicinal Products (CTIMPs) a Development Safety Update Report (DSUR) is required to be submitted to the MHRA annually. The DSUR should be submitted on the first anniversary of (a) the date of the first Clinical Trials Authorisation (CTA) approval (trials starting after 1 May 2004) (b) the date of the original exemption (trials commenced under an exemption) or (c) the date of the first marketing authorisation granted in the EU (marketed products) and thereafter annually until the MHRA has been informed of the closure of the trial a DSUR must be compiled and submitted. Preparation and submission of the DSUR will be the responsibility of the CI, supported and co-ordinated by the sponsor if required.

For UH Bristol and University of Bristol sponsored trials, R&I will notify the Chief Investigator that a DSUR is due, and advise the due date. The completed DSUR should be submitted to R&I for review prior to submission to the MHRA.

Further information regarding safety reporting for CTIMPs and details of how to submit DSURs can be found here: /research-innovation/information-for-researchers/setting-up-and-running-a-clinical-research-study/what-to-do-when-approval-is-received/safety-reporting-(adverse-events)/

End of study reports

At the end of a research study the CI will be expected to:

  • Notify review bodies that the study has ended and provide final reports;
  • Make arrangements for future use of research data and samples;
  • Fulfil commitments to study participants, such as providing information about the outcome(s) of the research and care after research;
  • Publish the results of your research.

The REC which gave a favourable opinion of the research and the MHRA (if applicable) must be notified of the end of a study, in writing, using the appropriate form within 90 days of its conclusion. There are separate forms for use in CTIMPs and all other research, which can be found on the HRA website: http://www.hra.nhs.uk/research-community/end-of-study-and-beyond/notifying-the-end-of-study/

For UH Bristol sponsored studies a copy of the completed end of study notification(s) should be sent to R&I, preferably as a pdf via email to research@uhbristol.nhs.uk.

Final Research Report

The CI should also send a summary of the final research report to the REC within 12 months of the end of the study. For CTIMPs a copy of the report should also be sent to the MHRA.

There is no standard format for final reports. As a minimum, you should include whether the study achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants.

For studies where UH Bristol are acting as Sponsor, a copy of the report should also be sent to the Research & Innovation Department (R&I), preferably as a pdf via email to research@uhbristol.nhs.uk.