Data management {19}
Data entry will be carried out by the investigators of each study center after the participation in training session before the beginning of the study to standardize procedures, including data collection.Investigators may contact the coordinating center to solve issues that may arise.Only authorized staff will be able to access the REDCap system. A two-step login procedure is needed to access the system. The first step requires the login with username and password. After the completion of the first step, an e-mail is sent to the user by the system with a verification code to be entered in the second step login, which expires after two minutes.Investigators will only be granted access to the records of their own patients but not to those stored in the entire database.The data will be automatically stored by REDCap, with backups planned every 4 h.During the creation of data collection sheets, when possible, the data format and range of plausible values will be set. If the input value is outside the defined range, a warning message will automatically appear to the researcher.Data will first be collected with a paper support and, after having checked for completeness and consistency, will be entered in REDCap.After the end of data collection:
Data provided by the centers will be checked for missing data, plausible, possible, or non-permitted value ranges. When necessary, centers will be asked to correct them;Statistical techniques to identify inconsistencies will be applied periodically. The centers will be notified about eventual inconsistencies to correct them;The coordinating center will review detailed reports on screening, inclusion, follow-up, and data consistency and completeness. The coordinating center will take immediate action to solve any problems that may arise.Data will be entered in the final electronic database only after the CRFs have been cleared by the coordinating center.