Data management {19}
CRF
CRF
SOP instruct the entire study personnel on how to make data entries to eliminate differences. Protocol procedure data will be collected in a pseudonymized paper CRF where all entries have to be signed and dated by study personnel. Raw data of performance tests and biological specimen analyses will be stored digitally on local computers with access rights restricted to study personnel only. Two independent study employees will digitalize the results of paper-based performance tests and questionnaires after every session. Daily backups of local IT infrastructure secure digital data. Additional backups of digital raw data on password-secured and encrypted external hard drives are automatically run.All original digital data and paper records, such as CRF, consent forms, and relevant correspondence, will be archived at the sponsor’s institute for a minimum of 10 years after trial completion, according to local regulations.