Managing amendments

Amendments prior to approval

The below guidance applies to research projects with NHS/HSC R&D Permission or HRA Approval only. If your study does not yet have these, please refer to IRAS Help pages for seeking NHS/HSC R&D Permission or HRA Approval.

Amendments post approval

Amendments are changes made to a research project after approval has been given. If you plan to make an amendment to your research project, you need to determine whether you need to notify the review bodies from whom you have received approvals.

It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial. The HRA provide examples of substantial and non-substantial amendments.

Detailed guidance on submission, categorisation and implementation of amendments can be found at HRA Amending an approval and the IRAS amendments help section:

    • Substantial amendments should be notified using a Notice of Substantial Amendment Form generated in IRAS by navigating to the Amendments tab of your project form, and clicking 'Create Notice of Substantial Amendment' button. It is not currently possible to submit amendments electronically in IRAS; you should therefore email your amendment (form(s) and any supporting documentation). The route for submission of your amendment to NHS/HSC will depend on a number of factors – please refer to the table in IRAS Amendments Help for instructions.
    • Non-substantial amendments and projects that do not have NHS/HSC REC review should be emailed to HRA.Amendments@nhs.net using this template.

On receipt of the categorisation email, the research team should forward this along with the amendment documents to participating NHS sites and research offices so that, where necessary, arrangements can be put in place to confirm the site’s continued capacity and capability or, for addition of a new site, confirmation of capacity and capability.

Adding new site(s)

If your study is a CTIMP (Clinical Trial of an Investigational Medicinal Product) you will need to submit a substantial amendment as described above.

If your study is a non-CTIMP (non-Clinical Trial of an Investigational Medicinal Product) you will need to submit a non-substantial amendment by email to HRA.Amendments@nhs.net.

The guidance on this page does not apply to:

    • Research Tissue Banks (RTB) and Research Databases (RDB) as these do not need NHS/HSC R&D Permission or HRA Approval;
    • Urgent Safety Measures. These should be sent to all participating organisations on receipt to ensure the participants' safety. Subsequent notifications, including resulting amendments should be submitted, as appropriate and according to relevant guidance; or
    • Notifications of the end of a study. These are not amendments and should be notified using the appropriate Notice of End of Study form.