Contracts and agreements can be concluded at many levels; Both inside and outside, both legally and legally. Examples are, but are not limited: the clinical trial agreement for biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of general practitioners highly active in research, the British Medical Association, the Medical Protection Society and the UK health departments. The Health Research Authority (HRA) supports the application of standard agreements. The content of the contracts and agreements should include: the NIC NHS and HSC should be set up through a subcontracting agreement with the participating NHS and HSC organisations. Appropriate data processing agreements should be concluded using the appropriate agreement model: the Triapartt agreement is intended to be used when the management of a commercial clinical trial is outsourced by the sponsor to a contract research organization. CRO mCIA is supported 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 Research Forum and the Institute for Clinical Research. “The revised MNCA should be used in place of the previous version 1.0, as it contains key clauses to bring it into compliance with the RGPD, and we will soon publish further guidelines on adapting existing agreements to the regulation. For non-commercial trials conducted in England, the HRA statement of activities can be used as an agreement between the sponsor and a participating website and can be found on the HRA website. The revised model agreement for non-commercial health research (MNCA) will be published in mid-June. Non-commercial sponsors and participating NHS organizations should use the MNCA in accordance with the guidelines and without modification. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK.
Contracts and agreements should come into effect before the start of a trial and be subject to periodic review to ensure they remain up-to-date and relevant. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions.