If the University is the research sponsor, the Research Governance, Ethics & Assurance Team reviews and approves all amendments to protocols and associated documents before submission to regulatory bodies. This is essential in order for the University to fulfil its sponsorship role and to ensure that indemnity can accommodate the changes proposed. The decision as to whether an amendment is substantial or non-substantial is ultimately the sponsor's.
Examples of substantial and non-substantial amendments are available on the HRA website.
In order for the Research Governance, Ethics & Assurance Team to review and approve both substantial and non-substantial amendments, amended text must be shown as a tracked change and a completed (but not locked) amendment tool needs to be provided. For further guidance refer to the IRAS help section. You can also register on the HRA’s learning management system to access the training video on how to complete the amendment tool. If you have any further questions, contact email@example.com.
Once the amendment is authorised by the Research Governance, Ethics & Assurance Team, you will need to submit both tracked change and clean versions of documents via the online amendment submission portal. For further guidance refer to the HRA training video on how to complete online submission of amendments.
CTIMP submission to MHRA should be made through:
- MHRA submission platform for applications submitted to the UK only – European Commission 'Annex 2' form is only required for ‘bulk’ amendments, where the same change will affect many trials simultaneously
- the Common European Submission Platform (CESP) for regulatory submissions made through European procedures
The Research Governance, Ethics & Assurance Team needs copy of the approved letters and an amendment should not be implemented until all approvals are in place.