Plans for assessment and collection of outcomes {18a}
thereinQuality
Investigators are responsible for the assessment and collection of outcomes, baseline, and other trial data. Data will be entered in the electronic case report form by delegated team members and will be monitored by trained clinical research assistants (CRA) designated by the sponsor. The digitalized version of the case report form is provided in Supplemental Material The investigator and the members of their team will accept to make themselves available during the quality control visits performed at regular intervals by the CRA. During these visits, the following elements may be reviewed:Informed consentRespect of the study protocol and the procedures defined thereinQuality of the data recorded in the case report form: accuracy, missing data, consistency of the data with the source documentsManagement of the experimental treatments/strategiesDeclaration of serious adverse eventsAll visits will be the subject of a written monitoring report addressed to the investigator of the site visited and to the study coordinating structure.