Ethical and regulatory requirements
The study will be performed in accordance with ethical principles that have their origin in the Declaration of Helsinki, including Decree No. 2016 − 1537 of November 16, 2016 on research involving human subjects, and are consistent with ICH/Good Clinical Practice, and applicable regulatory requirements Patient Data Protection; in France, CNIL.Before carrying out research on humans, the sponsor is required to submit the project to the opinion of one of the competent institutional ethical committees (Committee for the Protection of Persons: CPP) and to the regulatory authority (National Agency for the Safety of Medicines and Health Products: ANSM).Prior to the implementation of the research on a person, the eligible subject will be fully informed by the investigator during the consultation, and after a period of reflection, a written informed consent form will be collected.The information will also include information on data handling in accordance with the revised French Data Protection regulations including the European General Data Protection Regulation N° 2016/679.