Studies sponsored or co-sponsored by NHSG/UoA, require all proposed amendments to be submitted to the Sponsor first. The sponsor will then make the decision as to whether the amendment is substantial or non-substantial. No amendments should be sent for approval or notification to regulatory authorities without first having been approved and designated by Sponsor.

Remember that no amendment can be implemented, unless for immediate safety reasons, until all approvals are in place. Until this has happened the study has to continue according to the already approved protocol and related documents.

Instructions on how to process your amendment correctly can be found on our SOP and Templates page.


Study Management

 

Consent and recruitment Progress and Safety Reporting Management and Monitoring Inspection and Audit End of Study Analyse Data Final Reports