Go No Go process

Ethical criteria are essential in any clinical trial. Participating volunteers must be informed and should give informed consent to their inclusion in the trial. They must be warned of the potential risks exhaustively.


In France :


A) the validation by a “Comité de Protection des Personnes” is compulsory. This committee will give its decision by checking the scientific and medical interest of the study, its risk / benefit ratio, its compliance with good practices , especially with regard to the sponsor and the CRO, the existence of an insurance policy to compensate the trial participants in case of damage.


Financial links between investigators and trial sponsors, when they exist, must be stated. Conflicts of interest should be avoided.


B) the test must obtain the clearance of  the ANSM (1800 clearances issued per year approximately).