Changes that you make to your protocol and related documents after the project has been approved are called ‘amendments’. Amendments may be substantial or non-substantial
- Substantial amendments involve significant changes to the design and methodology of a research project.
- Non-substantial amendments do not involve significant changes to the design and methodology of a research project.
Definitions of substantial and non-substantial amendments
A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:
- the safety or physical or mental integrity of the subjects of the study;
- the scientific value of the study;
- the conduct or management of the study; or
- the quality or safety of any investigational medicinal product used in the trial.
For all studies, it is the responsibility of the sponsor to determine whether an amendment is substantial.
A detailed list of examples can be found on the HRA website of substantial and non-substantial amendments : http://www.hra.nhs.uk/resources/after-you-apply/amendments/substantial-and-non-substantial-amendments/
Changes to contact details for the sponsor (or the sponsor’s representative), chief investigator or other study staff are minor amendments but should be notified to the main REC for information.