Clinical Trial Agreement En Francais

The single agreement is concluded between the sponsor and the health care institution. If the parties intend to compensate a third party (under the conditions described below), that third party must also sign the agreement. If the research is conducted in several health facilities, each agreement must have the same identification, billing and payment provisions that the sponsor`s agreement contains. The final text adopted on 1 December 2015 applies to clinical trials also conducted in health centres and health organisations that do not receive patients. The management of the additional costs must be the subject of an agreement between the promoter, the legal representatives of each structure concerned and, if necessary, the legal representative of the structure that receives the financial equivalent paid by the sponsor. This agreement must be in line with a standard agreement established by the Minister of Health (this is the single agreement). This agreement must be signed by the participating examiner and forwarded to the National Medical Doctor Society for compliance verification and verification. On September 8, 2015, the Ministry of Health adopted a new regulation (Instruction No. DGOS/PF4/2015/282) on the evaluation of the use of this unique agreement in public hospitals.

Indeed, the ministry wishes to monitor the impact of this unique agreement on the negotiation period or the attractiveness of France with regard to clinical trials. Public centres may receive public funding from the Ministry of Health if they use this unique agreement to conduct clinical trials and if they meet the aforementioned deadlines and other requirements (e.g. B the time between the signing and the actual opening date of the centre or the number of patients). This model is a tool to speed up the negotiation and signing of the procedure with public hospitals. The sponsor may negotiate certain clauses, but the provisions of the single agreement are generally acceptable and current, particularly with regard to the provisions of the French Sunshine Act. The convention applies to all research involving therapeutic acts on humans. It channels the financial flows associated with commercial clinical trials and is for financial interests without any other agreement. The single agreement aims to simplify and accelerate the completion of commercial clinical trials between private sponsors and French healthcare institutions by providing a simple and binding model of reducing transaction costs. With this tool, the government hopes to increase France`s competitiveness in biomedical research. The single agreement will be signed within 45 days of the sponsor`s demerat. If the trial takes place at multiple sites, an additional 15 days applies to each agreement with associated entities.

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