Developing these pages will be ongoing and, if you share your views and ideas, it will help us to continue to improve this important resource. Therefore, your feedback will help us to improve these page and ensure that it covers everything that you need it to cover. Please complete this feedback form to submit any comments or suggestions.
e-Pathway: Project Management
Amendments
What is an amendment?
What is an amendment?
Amendments are changes to the protocol, supporting documents or any other information that has received external approval, for example from the HRA, REC or MHRA. It is important to ensure that all stakeholders in the project are kept informed of amendments, e.g. sites and collaborators.
Further information and guidance on the process for making amendments is available on the Research Governance Team’s ‘After Sponsorship is awarded’ page and in the UoB Project Setup SOP (UoB-SET-SOP-001) [Word - 346 KB]. The HRA website also has general guidance on amendments.
Substantial & non-substantial amendment management
Substantial & non-substantial amendment management
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 researchgovernance@contacts.bham.ac.uk 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].
Quick links
Your Feedback
e-Pathway
e-Pathway
The clinical research e-Pathway provides a roadmap to guide researchers during the lifetime of their research projects. Click on the links to take yourself to the stage that is of interest. You can also use the roadmap image on each page for navigation.
From Idea to Proposal
Applying for Funding
Project Setup
Green Light - Ready to Go?
Project Management
Project End
Need help with your project? See who can help.
For an overview of the e-Pathway, return to the homepage