Amendments to your study

All amendments made to your study (including addition of personnel, extension of timelines etc) whether minor or substantial must be notified to the R&D office at each NHS Trust who approved your study BEFORE implementation (unless they need to be implemented for safety reasons). All substantial amendments also require submission and approval from the NHS REC who approved your study PRIOR to implementation (unless implemented for urgent safety reasons).

Please note – all amendments must also be submitted to the host Trust of both PICs (Participant Identification Centres) and sites.

If your study was approved by any other body (such as MHRA or NIGB) you may also need to submit your amendment to those bodies as well.

Substantial Amendments

A substantial amendment is defined as a change to the terms of the REC application, the protocol or any other document submitted with the application, which significantly affects one of the following:

• The safety or physical or mental integrity of study participants
• The conduct or management of the study
• The scientific value of the study
• The quality or safety of any investigational medicinal product used in the study

Submission of Substantial Amendments

All substantial amendments must be detailed on a substantial amendment form, available through IRAS. The substantial amendment form and all associated documents must then be submitted to both the REC and R&D office as detailed in IRAS:

• for studies approved via CSP – email to the lead CLRN
• for those approved outside of CSP - email to the R&D of each host Trust

You will need to provide the R&D office with a copy of the REC approval letter for the substantial amendment once it has been received.

Minor Amendments

Minor amendments must be notified to the R&D office who approved your study. It is not necessary to notify the REC of minor amendments, however it can be useful to do so, particularly where these incorporate a change of address or contact details.

Submission of Minor Amendments

Minor amendments should be detailed in a letter or email together with any accompanying documents and:

• for those approved via CSP – emailed to the lead CLRN
• for those approved outside of CSP - emailed to the R&D of each host Trust