Making amendments to an active trial
Making amendments
If you need to make any changes to a research project/trial after it has been approved, then you need to request an amendment.
Amendments are designated as either substantial or non-substantial, depending on the nature of the change.
A substantial amendment would be a change to the design and methodology of a research project/trial.
A non-substantial amendment is a smaller change and could include things such as changes to documentation used by the research team to record trial data, or changes to funding arrangements.
In all cases, the amendments should be requested, documented and if approved, consistently applied.
How we can help
For advice and information about making an amendment, please contact the Research & Innovation Governance Team: ResearchSponsor@nuh.nhs.uk
For further guidance
NUH Standard Operating Procedures
Our Standard Operating Procedures (SOPs), templates and forms are designed to provide detailed instructions for all stages of the research process at NUH.
You can find the up-to-date information in our document library here.