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Reporting

During the course of your research study you will be required to submit annual and final reports to regulatory and funding bodies. The types of reports you will be expected to complete are as follows: (this is not an exhaustive list)

  • Progress report to Funder
  • Progress report to Research Ethics Committee (REC)
  • Safety Report to Research Ethics Committee (REC)
  • Development Safety Update Report (for Clinical Trial of an Investigational Medicinal Product (CTIMP) to Medicines and Healthcare products Regulatory Agency (MHRA)
  • Final reports to REC/MHRA  

Your sponsor may also have additional reporting requirements which they should discuss with you at the start of your research. All reports will require sponsor review and approval prior to submission.

Further details of reporting requirements can be found on the Health Research Authority (HRA) website and for UH Bristol sponsored research, in the SOPS: SOP_009 Research Safety Reporting and SOP_002 Research Sponsorship at UH Bristol.