For a multi-center trial, the signing period with the associated centres is limited to 15 days, with the agreement signed with the associated centres being a duplicate of the agreement with the Coordination Centre. 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. On 17 June 2014, the Ministry of Health issued on order (instruction no DGOS/PF4/2014/195) establishing a single model agreement for clinical trials carried out in public centres (i.e. public hospitals). This unique agreement is intended to regulate the contractual relationship between the sponsor (pharmaceutical laboratory), the public centre and the auditor employed by the Centre, but it can also be used in the case of a multi-center trial for all public centres participating in the clinical trial (called “associated centres”). 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. While the convention had remained unique in the experimental phase for a few years, which saw 2016 National Heath Law enacted on January 6, 2016, the implementation of the convention forced unique for all new clinical trials started after November 17, 2016. The sponsor must provide the products used for the clinical trial free of charge. This unique agreement is a binding model for agreements between health care facilities, health care homes or health care centres (Health Care Institutions) and sponsors for the operation of commercial clinical studies involving individuals. 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.

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. 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. During the reading of the bill by the French Senate, the above provision was amended to allow the inclusion of a third party in the agreement that receives financial assistance, as is sometimes the case in practice.

Posted by / april 8, 2021
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