Composition of the data monitoring committee, its role and reporting structure {21a}
MINOR, EVENT
The medical procedures used in this trial comply with the most recent recommendations of the Declaration of Helsinki and French Public Health Law 2004–806 of August 9, 2004, on subject protection and safety in accordance with good clinical practice. A person mandated by the sponsor will ensure monitoring of this trial to guarantee that accurate, full, and reliable data are collected. The level of monitoring will be adapted to the low risk of the study.At the end of the study, the data review committee, comprising the data manager, the biostatistician, and an independent dermatologist, will review all deviations from the protocol. Other members may join the committee to provide some details on the context of each deviation. The committee will qualify deviations as major or minor and shall clarify the relevance of the data with respect to these deviations: conservation of the data (for minor deviation) or exclusion of the data (for major deviation). Major deviations can affect subject safety or rights. Additionally, by definition, the intention-to-treat analysis requires that all data be kept for the analysis, even major deviations, except in the event of absence or withdrawal of written consent that systematically results in the exclusion of any data on the research.