Data management {19}
CRF
CRF, DELETION
The trial Case Report Form (CRF) is the primary data collection instrument for the trial. For this project, electronic Case Report Forms (eCRFs) will be used. The Clinical Data Management System [“SecuTrial”] is validated and changes are tracked via an audit trail. The Center for Clinical Trials Tübingen (ZKS) will monitor the correct completion / perform plausibility checks of the data stored in the eCRFs to avoid discrepancies with the source data. Implausible or missing data will be queried. The data from all centers will be entered in a central data base (secuTrial) provided by the Institute for Clinical Epidemiology and applied Biostatistics (IKEaB, University Tübingen). The system secuTrial is validated and used by several centers for clinical trials in Germany. It is linked to the central data center of the University Hospital Tübingen (UKT) and to which only authorized staff of the IKEaB has access. The data managing plan (including digital data storing and archiving) of the IKEaB will comply with all legal requirements. The system secuTrial provides an audit trail for all activities (data entry, modification, and deletion). A role system allows access to selected patients and different rights (reading, writing) for different investigators. The IKEaB will provide an intensive training for all users of this system during the study.The correctness of entries in CRFs will be confirmed by dated signature of an authorized investigator or delegated investigator. Data will be entered into the eCRF using an access-controlled, GCP compliant, validated and audit-trailed system by authorized staff of the investigational site. Plausibility of the data will be checked as implemented in the CRF. Entered data will be monitored on a regular basis.. Implausible data and missing data will be queried. The database will be locked after completion of entry, cleaning of data and final data review. All relevant trial data and documents (CRF-worksheets, source data and Investigator Site File (ISF) including subject identification list and relevant correspondence) will be archived by the principle investigators for 10 years according to local law or regulations.