After launching our online amendment tool on the Integrated Research Application Service (IRAS) earlier this year, we’ve been listening to feedback and have made some refinements.
Each year the HRA handles over 17,500 amendments to studies - changes made to a research project after approval from a review body has been given. The amendment tool categorises each amendment and provides tailored guidance on submission, identifying any review bodies an amendment needs to be sent to, based on the changes that are being made to a study.
Taking into account feedback, both from applicants making amendments and our Research Ethics Committees, we have:
- adapted the colour contrast in the form to make it easier to read
- changed some of the menu options to clarify between the options for CTIMPs and other study types
- added more space for applicants to fill in and describe the reason for the amendment
- introduced automatic text re-sizing so that all the information can be seen
- re-named the tab that lists all possible changes to a study, provided for reference purposes, to the ‘glossary of amendment options’ to make its purpose clearer
You can access the amendment tool on IRAS.
Since 2 June 2020, all applicants who make an amendment to project-based research 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.
You can find more information about amending an approval on the HRA website.
The amendment tool was launched at the same time as online amendment submission allowing applicants to submit their documentation via a new part of the IRAS website rather than submitting by email, making it easier for applicants to track the submission history of their amendments.