The Sole agreement
The Sole agreement is a contractual obligation for clinical research in France.
The Sole agreement is neither a law nor a regulation. However, since the Decree 2016-1538 of November 16, 2016, the Sole agreement is a mandatory "standard contract" which must be applied for all clinical research with a commercial purposes in France.
Thus, the “coordinating” healthcare establishment negotiates the amount of costs and additional hospital costs of a clinical trial with the sponsor using a fee chart, the amounts of which are set by ministerial decree, and are identical for all healthcare establishments, whether public or private. This financial evaluation is then imposed as is and without reassessment on the other healthcare establishments participating in the clinical trial (“associated establishment”).
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It is intended to be used identically by all French establishments, houses and healthcare centers participating in the same research involving the human person.
Why can't study centers manage patient reimbursements themselves?
During a clinical trial, all study centers are bound to the sponsor by a single agreement. Therefore, it is impossible to foresee the costs incurred by a patient and/or compensation because it is not a question of hospital costs and surcharges. They are simply not included in the Sole agreement, which cannot be modified.
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The study centers are therefore not authorized, through this contract, to manage this type of fee, either by advancing the costs to the patient and re-invoicing the promoter (on proof of payment) or by receiving a provisional "lump sum" from the promoter.
The latter must subcontract to an independent company such as TrialPEX.