For HRA guidance regarding amendments, please click here.

R&I Review of Amendments

All amendments must be notified to the NCA R&I department, where they will be processed by the RM&S team. Category A substantial and non-substantial amendments must receive Confirmation of Continuing Capacity and Capability (CC&C) from the RM&S team before the amendment can be implemented at any of the Care Organisations. For category B or C amendments, the RM&S team will issue an acknowledgment via email.

All amendment documentation and, once received, the appropriate regulatory approvals, should be sent by email to

On receipt of the full amendment submission the Trust has 35 days to review and raise an objection to the amendment. The RM&S team will work alongside the delivery teams and service departments to assess continuing capacity and capability for the study. On completion of the review, providing all regulatory approvals have been received and no objection has been raised, the RM&S team will issue an email to confirm CC&C and the amendment can be implemented.

Skip to content