From 2 June, all applicants making an amendment to project-based research will need to complete the amendment tool and submit their amendment online. The tool replaces the Substantial Amendment Notification Form, and Non-Substantial Amendment forms. For CTIMPs, the EudraCT Annex 2 amendment form will still be required and can be completed within the tool.
Amendments to Research Tissue Banks and Research Databases will also be submitted online from this date, but will not need the amendment tool.
To help with these changes, we have now published:
The amendment tool and full guidance about the new process for handling amendments
For queries on using the amendment tool or how to submit your amendment online, please contact:
For England and Wales led studies: email@example.com
For Scotland led studies: firstname.lastname@example.org
For Northern Ireland led studies: Research.Amendments@hscni.net
Mary Cubitt, Director of the Research Systems programme
‘The online submission of amendments means that applicants can submit their documentation directly – via a new part of the IRAS website - without having to email them over. This will make it easier for applicants to track the submission history of their amendments.
‘We are also launching a new amendment tool. This categorises each amendment and provides tailored guidance on submission. It will identify any review bodies an amendment needs to be sent to, based on the changes that are being made to a study.
‘Together we hope this will make implementing amendments more straightforward and concise – benefitting health researchers across the UK including those working on COVID-19 studies.’