The site-specific assessment is a local assessment of the suitability of a local site, facilities and research staff to a previously approved multi-centre study. This action is usually carried out by a local REC or research and development office. 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 highly active general practitioners, the British Medical Association, the Protection Medical Society and UK health authorities. The Health Research Authority (HRA) supports the application of standard agreements. The Helsinki Declaration is a statement of ethical principles developed by the World Medical Association for: “Advice to Physicians and other participants in medical research with human subjects” Based at the University of Cambridge, the THIS Institute`s manifesto states that “our goal is to create a leading scientific heritage for the NHS, in order to improve the quality and safety of health care. We are inspired by a highly participatory collaborative ethic, which combines academic rigour with the real concerns of people who use and work with the NHS. “www.thisinstitute.cam.ac.uk/ These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions. The accompanying guidelines provide more general information, an overview of changes from the 2011 versions, and additional information on how models should be used and under what circumstances. A key result – COS in short – is a list of important things to measure (important “results” when researchers compare different “interventions” for a given health condition.
Using a primary outcome rate helps researchers compare how different “interventions” work, as all studies report the same “results.” 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. One of the Health Services Research Unit`s (HSRU) research programs focuses on the evaluation of health technologies. For more information, visit the HCA website. The organisational information document is a key component of the UK Local Information Pack for commercial and non-commercial research projects. It replaces activity declarations used for non-commercial studies in England and Wales; and the NHS/HSC Site Specific Information (SSI) form in Scotland and Northern Ireland. See www.myresearchproject.org.uk/help/hlpsitespecific.aspx#UK-Local-Information-Pack-OID Clinical Trials Unit; are specialized research units that design, coordinate and centrally analyze clinical and other studies.