The tripartite agreement is intended to be used when the management of a commercial clinical trial is outsourced by the sponsor to a contract research organisation. The CRO mCIA is recommended by the UK Health Services, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS R&D Forum and the Institute for Clinical Research. The Clinical Trial Agreement model for primary care research (Primary Care mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of very active GPs, the British Medical Association, the Medical Protection Society and the UK Health Services. The Health Research Authority (HRA) supports the use of model agreements. Where a proposal is submitted on the basis of the model agreement, but which involves amendments, the sponsor must explain the reasons for the proposal. The model is structured in such a way that it meets the requirements of non-commercial sponsors and NHS (or other) organisations carrying out the research and has been designed as a single UK-wide contract template, meaning that it can be used regardless of where the promoter and research site are established. If hei is the sponsor, a specific data processing agreement must be concluded between the sponsor and the NHS organisation to meet the requirements of the GDPR. A simplified organisational information document is available, which can be used as a convention for the purposes of the GDPR. Each national coordinating function keeps a list of NHS organisations that choose to cooperate with certain higher education institutions under these agreements (in order to know when they need to request organisational information documents).
The decision to work in this way rests with NHS organisations. If you are not sure if any local agreements have been reached, please discuss this with your HEI/NHS sponsorship team. For studies under the HRA authorization, the HRA Initial Assessment Letter (and the HRA Approval Letter) indicate the corresponding agreement for each type of site in a study. . . .