The amendment tool is designed to simplify the amendment process for applicants and online submission of amendments means that applicants can track the submission history of amendments.
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 Notification of Substantial Amendment (NoSA) and Non-Substantial Amendment forms.
NOTE: Amendments to Research Tissue Banks (RTB) and Research Databases will also be submitted online from this date. These will continue to use the Notice of Substantial Amendment Form, the amendment tool should not be completed for RTB or Research Databases.
To help with these changes, the following guidance has been published:
- The amendment tool and full guidance about the new process for handling amendments
- Training videos: amendment tool demonstration and how to complete online submission of amendments
For queries on how to complete the tool, questions on the results from the tool once complete 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
The new amendment tool should be used for all project-based research including amendments being made under the COVID-19 fast-track process. (Research Tissue Banks and Research Databases will continue to use the IRAS generated substantial amendment forms.)
The tool categorises the amendment and provides tailored guidance on how to submit. It will identify any review bodies the amendment needs to be sent to based on the changes that are being made to the study. It also provides detailed information about the amendment to participating sites.
The Notice of Substantial Amendment/annex 2 form can be generated by completing the tool. This version of the form can then be submitted to the REC and the MHRA (as required) when making a substantial amendment to a trial.
Online amendment submission portal
Once the amendment tool has been completed, follow the submission guidance provided in the submission guidance tab of the tool. If the amendment needs to be submitted, then the amendment tool, together with all the supporting documents, should be uploaded into a new part of IRAS and submitted using the online amendment submission portal.
For amendments to Research Tissue Banks and Research Databases the IRAS substantial amendment form should be submitted online in place of the amendment tool.
Applicants will need to set up a new login and password for the new part of IRAS. If applicants already have a login for any NIHR system or one of these new parts of IRAS they can use the same details. If applicants do not already have a login for those systems, they will need to set up a new login and password as guided by the system.
Once logged in, applicants will need to input the IRAS ID for the study as well as some other information regarding the study and amendment, some of which will need to be copied directly from the tool itself. Applicants can upload documents including a PDF of the tool itself. The system will issue an email to confirm the amendment has been submitted.
Upon submission the REC will be alerted to the amendment and it will then be shared with HRA and HCRW Approval / NHS/HSC R&D coordinating functions as applicable to the project.