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If the University is the research sponsor, CTRG 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 CTRG to review and approve both substantial and non-substantial amendments, amended text must be shown as a tracked change.
Once the amendment is authorised by CTRG, you will need to send both tracked change and clean versions of documents to relevant review bodies. Details of where to submit your amendments can be found in the IRAS help section.
A substantial amendment is defined as change to the terms of the protocol or any other supporting documentation that is likely to affect to a significant degree:
Addition of new sites, or appointment of a new principal investigator at an existing trial site (for CTIMPs only), are substantial amendments since they change the conduct or management of the research.
For all non-substantial amendments, please complete the non-substantial amendment form template.
Submit the non-substantial amendment form, sponsor authorisation email, and any amended documents by email to the REC that originally reviewed the study
Information on HRA categorisation of amendment can be found in the IRAS help section.