A list of websites and downloadable documents developed to support research and development has been collated. Health and Care Research Wales does not take responsibility for any content provided by external organisations.
The 2018 revised model Clinical Trial Agreement (mCTA)with guidance notes for the mCTA and CRO mCTA are designed to be used without modification for industry-sponsored trials in patients in hospitals throughout the UK Health Service.
The mCTA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK.
The model Clinical Investigation Agreement (mCIA) is designed to be used without modification for company-sponsored commercial research involving medical devices in patients in hospitals throughout the UK Health Service.
2014 versions of the mCIA have been developed to ensure compliance with the law in the relevant jurisdiction and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all versions of the Agreement.
The Contract Research Organisation model Clinical Trial Agreement (CRO mCTA) is a tripartite agreement between:
The CRO mCTA is based on the bipartite model Clinical Trial Agreement, used by pharmaceutical companies and NHS organisations. It is tailored to be used without modification for CRO-managed trials in patients in hospitals throughout the UK Health Service.
2018 versions of the CRO mCTA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.
The Contract Research Organisation model Clinical Investigation Agreement (CRO mCIA) is a tripartite agreement between:
The CRO mCIA is based on the bipartite model Clinical Investigation Agreement (mCIA), which is for use by NHS Trusts and the medical technology industry. This tripartite agreement is for use when the management of a contract commercial clinical investigation is outsourced by the sponsor to a Contract Research Organisation. This agreement is endorsed for use by the UK Health departments, National Institute for Health Research, Association of British Healthcare Industries (ABHI), NHS Confederation, Medical Schools Council, NHS R&D Forum, Institute for Clinical Research and the UKCRC.
2014 versions of the CRO mCIA have been developed to ensure compliance with the law and to reflect regional institutional arrangements across the UK. The accompanying Guidance Notes cover all four versions of the Agreement.
The model Clinical Trial Agreement for pharmaceutical and biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and agreed by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly research-active general Practitioners, the British Medical Association, the Medical Protection Society and the UK health departments. The Health Research Authority supports the use of model agreements.
The 2013 Primary Care mCTA is designed to simplify and therefore speed up the process for signing off and initiating pharmaceutical and biopharmaceutical clinical trials involving patients in primary care. It is intended that the Primary Care mCTA is used routinely without modification by all pharmaceutical and biopharmaceutical industry sponsors of contract clinical research in which NHS patients are recruited in primary care.In such cases, no further review is necessary, saving money and time.
The model Industry Collaborative Research Agreement (mICRA) launched in February 2011 aims to support clinical research collaborations involving the pharmaceutical and biotechnology industries, academia and NHS organisations across the UK.
A decision tree is available to guide users in identifying when studies are collaborative and whether mICRA is applicable.
The mICRA was developed by a working group led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, universities, the NHS, and the Intellectual Property Office, worked together with expert legal opinion to develop a model Agreement that can support all collaborative research scenarios. Organisations involved in the working group have agreed a Statement of Endorsement encouraging its use, to streamline the contracting process for collaborative research.
LINC is a research database https://linc.abpi.org.uk/ which provides easy access to identify new collaboration opportunities. Using the database academics and clinical researchers can find opportunities online for collaboration with the biopharmaceutical industry - including funding, access to cutting-edge equipment, compounds and opportunities to build collaborative relationships.
The database also provides, for the first time, a publicly available and user-friendly central portal to see the different ways pharmaceutical companies are supporting open innovation, working with researchers across the UK both in hospitals and in universities. The ABPI LINC database has been launched alongside a booklet of industry-academic case studies in the UK, highlighting projects that are pushing the boundaries of medical science from better understanding diseases to clinical trials https://linc.abpi.org.uk/case-studies.
The database already has some 370 projects – ranging from funding opportunities for promising Dementia research, to an offer of 62 compounds available to academic scientists conducting preclinical research free of charge, plus free access to databases of drug-like bioactive compounds. ABPI LINC will be routinely updated when companies offer new projects. Users can view preclinical and clinical initiatives and search by compounds, funding, non-specific partnership, investigator-initiated studies, equipment and resources, collaboration facilitators and challenges – or a mix of these. The portal also allows people to search by company name to see what projects ABPI member companies offer.