Confidentiality {27}
In accordance with provisions concerning the confidentiality of data to which persons responsible for the quality control of a study involving human individuals have access (article L.1121–3 of the public health code), and in accordance with the provisions regarding the confidentiality of information relating, in particular, to the trial, the persons who participate, and the results obtained (article R.5121–13 of the public health code), the persons having direct access to the data will take all necessary precautions to ensure the confidentiality of the information related to the trials, to the persons participating and, in particular, with regard to their identity as well as the results obtained.These persons, as with the investigators themselves, are subject to professional confidentiality (in accordance with the conditions defined by articles 226–13 and 226–14 of the penal code).During the research involving human individuals or at its end, the data collected on the persons participating and sent to the sponsor by the investigators (or any other specialists) will be made anonymous.Under no circumstances should the names or the addresses of persons concerned appear.Only the first letter of the subjects’ surname and the first letter of their first name shall be recorded, accompanied by a coded number specific to the study indicating the center number and the inclusion order of the subject.The sponsor will ensure that each person participating in the research has given their written agreement granting access to the individual data that concerns them and strictly necessary for the quality control of the study.