Plans for assessment and collection of outcomes {18a}
Data will be managed in a database administered by the sponsor. Data entry will be performed by the investigators at each center and may be performed by any person on the task delegation list. The system used for the computerized database will be in accordance with the regulations in force, particularly MR-01. Access to the database will be limited to authorized persons only (sponsor team, investigation team, principal investigator), and rights (read, write, specific pages of the case report form, patients of the center or all patients, etc.) will be assigned according to their role in the study and their center. Authentication of users will be assured by means of a username and a password personalized for each user. Connections to the database will be recorded in the connection history.Consistency tests may be scheduled depending on the level of risk and/or impact of the study as defined by the sponsor. Following the execution of these tests, requests for clarification (queries) may be sent to the investigators to correct or confirm data entered in the database. Depending on the level of risk and/or impact of the study, a preanalysis committee may meet before the data are exported to qualify the deviations identified during the study and to decide whether or not to include the data collected in the study.