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Amendments made to any study specific documentation must be reported to ethics, the MHRA (if the research study is a CTIMP or medical device) and R&D. The NRES require changes to studies to be reported with those deemed substantial to be approved. Guidance on whether an amendment is substantial or non-substantial can be found here. Please submit the following documentation to R&D to ensure management Approval of your study is still valid:

  • Copy of the Notification of Amendment form sent to ethics
  • Copy of the favourable opinion of the amendment from ethics
  • Copies of all documentation listed in the amendment favourable opinion letter received from ethics
  • Copy of amendment approval letter from the MHRA (only required for CTIMP or medical device).

Once the above documents have been satisfactorily reviewed by R&D you will receive an email confirming R&D Approval is still valid