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.
ACCESS TO DATA AND REPORTS
Electronic records of all our projects are open to users at various authorization levels and all data, including completed projects, can be accessed quickly at any time. When the Sponsor requests the data of a project, it will be shared with our OwnCloud (www.owncloud.org) encrypted file management and sharing system, which runs on our own servers, developed in accordance with the Personal Data Protection Law and the General Data Protection Regulation (GDPR) of the European Union. It is ensured that they can access the files on our server through fixed links with a password and with in a limited time.
All data on the servers are backed up automatically in daily, weekly and yearly periods. Annual backups are stored in the bank vault, keeping data loss to a minimum level.
For internet and data security, we have virtualized server systems with antivirus software and dual firewalls which are updated daily.