Clinical Trial Agreement France

This order of September 8, 2015 indicates that the single model is optional for private centers. It specifies that, in order to develop the quality of the clinical trial, financial interest may be granted by the proponent in addition to compensating for the costs generated by the protocol. 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. In fact, French practice often involves associating an association or foundation with the conduct of a clinical trial. Another amendment is that this agreement must be forwarded to the Medical Doctor Society for compliance verification. The sponsor must provide the products used for the clinical trial free of charge. 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 aim of the development of this single draft agreement for the conduct of clinical trials is to strengthen the competitiveness and attractiveness of French hospitals for clinical trials. A clear draft agreement should simplify the internal process at the hospital and speed up the signing process. The negotiation period between public hospitals and pharmaceutical companies should therefore be reduced. 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. 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.

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. On 17 June 2014, the Ministry of Health issued a commission (instruction no DGOS/PF4/2014/195) establishing a single model agreement for clinical trials carried out in public centres (i.e.:

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