This site uses cookies to store information on your computer. I'm fine with this Cookie information
Cookie Control


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