UoMCTSOP09 Amendments v7 Summary: The purpose of this SOP is to define the process and procedures for submitting substantial and non-substantial amendments for CTIMPs/Medical Device Trials to the Sponsor(s), the main REC, the HRA and the MHRA; and for implementing the approved changes. Type: Guideline Owner: Research Governance and Integrity   This document requires CAS authentication Contact email: clinicaltrials@manchester.ac.uk Last modified: 12/12/2025 Link to this document: https://documents.manchester.ac.uk/display.aspx?DocID=11002 Edit (only Administrators)