Amendments

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.