France Clinical Trial Agreement Template

At the same time, the government has included in the draft law of the new health law (“Law to modernize our health system”) a provision on the mandatory use by public hospitals of this single agreement in order to give a legal basis to the single agreement. 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 Ministry of Health hopes that this new provision will improve the development of clinical trials in France. 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. The objective of developing this unique contract model for conducting clinical trials is to strengthen the competitiveness and attractiveness of French hospitals for clinical trials. A single contract proposal should simplify the hospital`s internal process and speed up the signing process. The negotiation period between public hospitals and pharmaceutical companies should therefore be shortened. On 8 September 2015, the Ministry of Health adopted a new regulation (Instruction No DGOS/PF4/2015/282) on the evaluation of the application of this single agreement in public hospitals. Indeed, the ministry wants to monitor the impact of this unique agreement on the timing of negotiations or on the attractiveness of France in terms of clinical trials. Public centres may receive public funding from the Ministry of Health if they use this single agreement to carry out clinical trials and if they meet the above-mentioned deadlines and other requirements (e.g.

B the time between the signature and the actual date of opening of the centre or the number of patients included). 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 sponsor must provide the products used for the clinical trial free of charge. The Ministerial Order of 16 November 2016 gives the Convention a unique model and describes in detail how to calculate these costs. The single agreement is concluded between the sponsor and the health institution. If the parties intend to compensate a third party (under the conditions described below), this third party must also sign the contract. 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 single agreement must be signed within 45 days of receiving the sponsor`s proposal from the health facility. If the test takes place at more than one site, an additional 15 days applies to any agreement with related entities. The goal is ambitious, but a recent survey shows that, despite the adoption of the Single Convention, the conduct of clinical trials still takes too long.

This single agreement sets out both the costs to be reimbursed to the hospital (which have normally been the subject of a `hospital agreement`) and the remuneration for the conduct of the clinical trial by the examining physician, a member of the hospital staff. . . .

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