Ongoing Studies

Post Approval

Amendments

• Applicants need to e-submit submit substantial amendments to HRA through IRAS. The HRA Approval Team then share the submission to the relevant REC.
• Other non-substantial/minor amendment(s) should be sent to hra.amendments@nhs.net
• The HRA will categorise the amendment within 5 days.
• The applicant should then send the amendment and the categorisation information to participating NHS R&D organisations so that, where necessary, arrangements can be put in place to confirm the site’s continued capacity and capability.
• The HRA issue a HRA Amendment Approval email.
• The sponsor then communicates HRA Approval to R&D and NHS sites.
• NHS sites confirm continuing participation, where necessary.
• Amendments have been grouped into three different categories (Category A, Category B and Category C) for the purpose of handling them in a manner appropriate to the amendment.

To add a new site:

• For a non-CTIMP (non-Clinical Trial of an Investigational Medicinal Product) you will need to make an amendment and send an email to hra.amendments@nhs.net
• For a CTIMP (Clinical Trial of an Investigational Medicinal Product) you will need to make a substantial amendment in IRAS.

For studies where the lead NHS R&D office is in Northern Ireland, Scotland or Wales amendments are categorised by the lead nation and shared across participating UK nations.

Guidance on submitting Amendments to projects involving the NHS/HSC is also available on IRAS help pages.

The guidance on this page does not apply to:

• Research Tissue Banks (RTB) and Research Databases (RDB) as these do not need 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 to the REC using the appropriate Notice of End of Study form.