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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).