Data management {19}
CRF
CRF
In addition to the investigators, only persons authorised by the investigators are granted access to the eCRF. The accessed data may not be passed on to third parties. The scope of authorisation and the associated rights in the eCRF are controlled by data management via appropriately defined user roles. The data relevant to the trial protocol (including the data of trial subjects who were prematurely excluded from the trial) must be documented in the eCRF pseudonymously, promptly, legibly (without the use of abbreviations), completely and in accordance with the source data. Implausible values, which are displayed during data entry by programmed checks, must be checked by the trial site and corrected if necessary. If a correction is made in the eCRF, the reasons for it must be given. By means of the audit trail, all data and corrections are automatically logged with the date, time and username of the person entering the data. All old entries are retained and can be retrieved at any time.A paper-based interim CRF is provided to the trial site as part of the investigator site file. This enables timely documentation in accordance with the protocol if the eCRF is not available (e.g. due to a system malfunction). The authorised persons will transfer the data immediately from the interim CRF to the eCRF as soon as the fault has been rectified.The correctness and completeness of the documentation are confirmed by the authorised persons after each visit to the eCRF. Once the documentation for a subject has been completed, the PI finally confirms the documentation for this subject in the eCRF.Queries by the sponsor or its representatives must be checked by authorised persons using the source data and answered directly in the eCRF. Any resulting corrections must be made in the eCRF. The data management plan describes the trial-specific approach of the individual processes for traceability and completeness of the relevant data (see 