Overview

A modification is generally considered to be any change made to the study that impacts the ethics review application, the protocol or any other supporting documentation after the study has been approved by the Research Ethics Committee and the study has started.

A substantial modification is a change to the research study that is likely to have a significant effect on any of the following:

1. The safety, health, rights, physical or mental integrity of the subjects of the study;
2. The scientific value of the study, or the robustness or reliability of the data generated by the study;
3. The conduct or management of the study; or
4. The quality or safety of any investigational medicinal product or device used in the study.

A non-substantial modification is any change to the research study in terms of the REC application, the protocol or any other supporting documentation that does not meet the definition of a substantial modification.