Amendments

Amendments are changes to the study once initial approvals have been given. 

From 31st March 2016, where a project has HRA Approval the Sponsor/CI is expected to notify both substantial and non-substantial amendments using the appropriate form. There is some guidance prepared by HRA.

 

For studies where the lead NHS R&D office is in Northern Ireland, Scotland or Wales different processes apply and the categorisation will be undertaken by the lead nation.


The categorisation process provides information to NHS sites about whether the amendment may require consideration prior to implementation. 

Please find on the link the flowchart outlining the amendment process.



The Sponsor/CI remains responsible for providing details of the amendment, including copies of revised documents and notification of regulatory approvals, to all participating sites and R&D Offices. Please find on the link an HRA template for Sponsors to notify sites of the amendment www.hra.nhs.uk

Note for Pre-HRA Approval Studies: Amendments for studies set up using pre-HRA Approval processes are submitted in the same way as HRA Approval studies. Where the amendment introduces a new site for a pre-HRA Approval study the HRA Assessment Team will ask for the most up to date document set and the template agreements and costing information that will be used when working with the new site.