UKCRC Model Agreements

UKCRC Model Agreements Presentation notes: Before a research study can start contracts need to be in place that document the roles and responsibilities of the parties involved; this usually involves putting in place a formal agreement between the study sponsor and the site where the research will take place. However, consensus was that there was no standardised approach i.e. negotiation and agreements of contracts was taking place on study and site-specific basis. This was very time consuming and costly and often required legal advice. Solution to develop a suite of model or template agreements that could be used “off the shelf”. The UKCRC Partners have committed to supporting the development and use of these model agreements. Currently there are 4 agreements that have been published or are in development. These are: Pharmaceutical and biopharmaceutical clinical trials (mCTA): This model Clinical Trials Agreement (mCTA) was relaunched in October 2006 after updating and further negotiation of the original version that had been developed in response to recommendations from the Pharmaceutical Industry Competitiveness Task Force (PICTF). It was developed through collaboration between the Association of British Pharmaceutical Industry, Bioindustry Association and the Health Departments. It is intended for commercially sponsored pharmaceutical and biopharmaceutical clinical trials taking place in the Health Service. Different versions of the agreement are used in each of the UK nations. Clinical trials employing a contract research organisation (CRO; tripartite mCTA): This is a tripartite version of the mCTA, which is intended to be used in studies where a Contract Research Organisation (CRO) is involved. This agreement was launched towards the end of October 2007. Clinical investigation of medical devices (mCIA): This agreement is intended for use in regulated medical device studies (clinical investigations) in the Health Service. It is being developed in partnership between the Association of British Healthcare Industries (ABHI) and the Department of Health. Work on this agreement is well advanced and it is anticipated that it will be launched in 2008. Non-commercial research in the Health Service: Setting up agreements for non-commercial research is often particularly challenging as the parties may not have experience in drawing up these types of documents and/or the access to legal advice. The MRC, NHS R&D Forum and representatives of university and the NHS have been working together under the umbrella of the UKCRC to develop an agreement that can be used for a wide range of non-commercial research studies across the UK. The model agreement has been out for three rounds of public consultation and is now being finalised. Launch is anticipated in early 2008. Work on the suite of model agreements is consistent with and linked to other UKCRC activities to streamline the R&G environment, particularly those aimed at a streamlined and harmonised approach to permission to carry out research in the NHS (also known as R&D approval) Further information: Please see the UKCRC website: http://www.ukcrc.org/activities/regulationandgovernance/ or contact the UKCRC secretariat at info@ukcrc.org, phone +44 (0)20 7670 5452.