Amendments process flow chart
This flow chart documents the process for submission of clinical trial amendments to the Competent Authority (CA), Research Ethics Committee (REC), and relevant host organisation.
(1) Examples of substantial and non-substantial amendments are available on the HRA website. The decision as to whether an amendment is substantial or non-substantial is ultimately the sponsor’s.
(2) For studies that received their initial approval before the HRA process change on 31 March 2016, new sites will need to be added using the new HRA process. See the HRA website or contact CTRG for further guidance.
(3) Consider whether the amendment requires MHRA approval even if it does not require NHS REC approval.
(5) In Scotland, Wales or Northern Ireland you should submit the amendment to the REC and copy in email@example.com.