If the University is the research sponsor, CTRG reviews and approves all amendments to protocols before submission to regulatory bodies. This is essential in order for the University to fulfil its sponsorship role and to ensure that indemnity is not affected by the changes.
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:
- the safety or physical or mental integrity of participants
- the scientific value of the research
- the conduct or management of the research
- the quality or safety of any investigational medicinal product used
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.
If the amendment requires immediate implementation due to safety concerns (urgent safety measures) this must be discussed with the MHRA as soon as possible and a formal amendment submitted within three days.
In all other cases the REC, MHRA (trials only), sponsor and HRA or relevant NHS trusts (where required) must approve substantial amendments before they are implemented.
In order for CTRG and the relevant parties to review and approve amendments all documents must be provided in two formats: the original showing the amended text as tracked changes, and a clean version of the amended document.