A substantial amendment can be defined as an amendment to the protocol or any other study specific documentation, the terms of the REC application or the terms of the CTA application (as applicable) that is likely to affect to a significant degree the:
- The safety or physical or mental integrity of the subjects of the trial;
- The scientific value of the trial; The conduct or management of the trial; or
- The quality or safety of any investigational medicinal product used in the trial.
Other changes to the particulars of a study that qualify as substantial amendments include:
- A change of sponsor(s)
- Appointment of a new Chief Investigator and
- Extension of the research beyond the planned closing date for recruitment
A substantial amendment may not be made to a research study without the favourable opinion from the REC that gave a favourable opinion for the study (the main REC) and as applicable the MHRA. The only exceptions to this rule are:
- The Inclusion of a new research site or
- The Appointment of a new PI at an individual site
Both of these qualify as substantial amendments but as they require further SSA and approval from the REC there is no requirement for notice of amendment to the REC. These changes do still however need to be notified to the MHRA (as applicable)
