DATA MANAGEMENT
CONSTRUCTION OF DATABASE
The data obtained from the participants through the clinical study are entered in the Case Report Form (CRF) in paper form or electronically with Open-Clinica as e-CRF. The database is prepared by Novagenix, so that this data entry is made reliable, accurate and fastest. In addition, electronic data obtained from analytical devices in our analytical laboratory are automatically transferred to the servers and with our project information system, all the updates (application of dossier, bioanalysis, statistical calculations, reports etc.) are shared with our sponsors.
VERIFICATION AND CONTROL OF THE DATABASE
Data entry in Case Report Forms is entered and controlled by a single entry, double check and confirmation system. In case of any dispute in the CRF, the clinical center is contacted to ensure that the necessary controls are made and the data are corrected. While the electronic data obtained from our analytical devices are automatically transferred to the servers, transfer logs are also kept and these data are transferred via direct connections without being copied to the statistics program. Since the data transfer from the server to the analysis computer and from there to the statistics program is validated, data integrity and accuracy and robustness are guaranteed.
