NHS GG&C Responsibilities

Once R&D approval has been issued NHS GG&C has responsibility for:

ensuring investigators perform pharmacovigilance to required regulatory timelines as dictated by government legislation (CTIMPS only)

ensuring research teams are working to GCP standards as required by the EU Directive and Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended) (CTIMPS only)

following the trial to completion and ensuring regulatory requirements are met for the termination and final reports are submitted to ethics and/or the regulatory authority

capturing publication and dissemination, service benefits and other key research outputs

Multi-site Studies

Where a research study is being extended to sites outwith GG&C to other NHS organisations, R&D will generate multi-site agreements which set out the responsibility of each party. R&D regularly organise international trials which have global sites round the world, e.g. U.S.A, Australia, France and Japan.

Monitoring

R&D has a responsibility to monitor research studies conducted on its premises under ICH-GCP, the Scottish Executive Research Governance Framework for Health and Community Care (2nd edition February 2006) and the Medicines for Human Use (Clinical Trials) Regulations, 2004 No. 1031 (as amended). Please see the Monitoring and Audit section for more information.