NUH Research and Development Department reviews and authorises all research that takes place within the Trust. If changes are made to the study protocol the Research Department must be notified of the intended amendments, to enable reviews and confirmation of continued authorisation to be given.
The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involve only logistical or administrative aspects of the trial, e.g. change in monitor(s), change of telephone number(s).
Where changes are made to the design, methodology and analysis of the research study, with financial implications to the investigator, directorate, service department or Trust, the R&D Department will review these and approve. A typical example is an increase in patient numbers to be recruited.
Substantial amendments require approval by the Ethics Committee and MHRA before Trust Approval can be granted.
A copy of the amendment and the corresponding Ethics Committee correspondence and approval letter, as well as Regulatory Authority approval, is submitted to the Research and Development Department ( ) . If all documentation is satisfactory, NUH Research and Development Department will issue an Amendment Approval Letter. A copy of the Amendment Approval Letter is emailed to the Clinical Trials Pharmacist for all CTIMPs.
The Principle Investigator should file the approved amendment in the Investigator Site File with the protocol and file any superseded documents in the superseded documents section on the Investigator Site File.
It is also the responsibility of the Principle Investigator to file the approval letter from the Ethics Committee, Regulatory Authority and Research and Development Department in the corresponding sections of the Investigator Site File.
All staff involved with the study should be made aware of any amendments to the Protocol.
