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Page 2 of 2 What are the regulatory requirements ?
- Since August 27th 2006, France has been implementing the EU Clinical Trials Directive 2001/EC into national legislation (application decree n°2006-477 dated 26 april 2006) detailing new rules on good clinical practice for investigation of medicinal products.
- An advisory committee - the CPP (Comité pour la Protection des Personnes), an independent body constituted of medical, scientific and non-scientific members - warrants the protection of the rights, safety and well-being of human subjects involved in a trial - The AFSSAPS (French health security agency for health care), a dependency of the French Ministry of Health, grants permission to perform a study. - The subject voluntarily confirms his/her willingness to participate in a trial, after having been informed of all aspects that are relevant to the subject’s decision in participating. With the investigator, he/she documents his/her informed consent by means of a written, signed and dated informed consent form. - The Good Clinical Practice (GCP) is "an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects". - A request for authorization by the CNIL (a national committee for data protection) aims at ensuring the subject’s anonymity and the confidentiality of collected data. Centre CAP has been certified by the Ministry of Health since 1997.
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