Data management {19}
Cancer
CANCER, DELETION
Database development and administration are ensured by the North-West Canceropole Data Processing Centre (DPC) and under Caen University Hospital responsibility. Access is allowed to authorized people only through a highly secured system (VPN/SSL mode up to 128 bits; transmitted data encrypted). Its web interface allows study management via standard data entry in client/server and/or via the internet. Daily backup is made using two independent servers.Data protection is based on (i) the definition of authorization profiles, defining the functions or types of information available to a user; (ii) control of access to the software by a username issued by the administrator and a password; (iii) electronic signature of the data; (iv) secure access to data by the “owner” only; (v) the audit trail that tracks all access, modification, and deletion of data; (vi) exported files archived within the system; (vii) all plotted transfers and uploads and downloads; and (viii) the possibility of automatic identification of patients without nominative data (creation of a unique patient identification number (alphanumeric) to enable interoperability of the data recorded and preserve anonymity).Data quality is assured by pretesting and consistency checks during data entry. The software also includes a data management system of “queries.”Storage: The Ennov Clinical© application is made available in SaaS mode by ENNOV™, which outsources its server installation and hosting services (software and data) to OVH™.Backups are made daily (databases and servers). This is an incremental backup without overwriting data. A history is created allowing, if necessary, the recovery of previous data.Data management/quality: The data processing center has quality procedures relating to Good Clinical Practice (GCP) guidelines and the use of the software. The DPC has been certified by the French National Cancer Institute (INCa) since July 2007 and International Organization for Standardization 9001:2015 since March 2018.