Clinical Trial Agreement En Francais

According to the text adopted at first reading of the French National Assembly in April 2015, the management of additional costs for the hospital must be the subject of an agreement between the sponsor and the legal representative of the public hospital when a clinical trial is carried out in a public hospital. The agreement must comply with a standard agreement established by the Minister of Health. The single agreement aims to simplify and accelerate the conduct of commercial clinical trials between private sponsors and French healthcare institutions by providing a simple and mandatory model to reduce transaction costs. With this instrument, the government hopes to increase France`s competitiveness in biomedical research. The Single Agreement is a binding model for agreements between health institutions, nursing homes or health centres (“Health Care Institution”) and sponsors for the operation of commercial clinical trials on people. The Regulation also established that, using this single contract model, the optimal time between the sponsor`s invitation to conduct a clinical trial in the coordination centre and the signing of the agreement should be within 45 days. On 17 June 2014, the Ministry of Public Health published, by order (instruction No DGOS/PF4/2014/195), a single model contract for clinical trials conducted in public centres (i.e. public hospitals). The sponsor must make available free of charge the products used for the clinical trial….