Amendments are classified as either substantial or non-substantial depending on the proposed changes. The HRA provides guidance on which types of changes fall into which category, and further guidance is built into the amendment tool. For further information and a link to download the amendment tool, see the Research Governance Team’s ‘After Sponsorship is awarded’ page.
Please contact the Research Governance team via firstname.lastname@example.org if you are unsure how to categorise the changes you wish to make to your project.
Non-substantial amendments to CTU-managed trials should be processed according to CTU internal procedures. Please note that all relevant documents, amendment tools and regulatory responses (including those which simply confirm that no further review is required) should be forwarded to the RG team for logging as soon as possible.
All other amendments, including non-substantial amendments to any projects which are not managed via the CTUs, require the authorisation of the Sponsor prior to submission to the HRA/REC
For further information, see the UoB Essential Documents Development & Maintenance SOP (UoB-ESD-SOP-001) (Word - 401 KB) and the UoB Project Setup SOP (UoB-SET-SOP-001) (Word - 346 KB).