a web-based system for collecting and managing CRF data,
using a standard web browser
Compliance with FDA 21 CFR part 11 requirements and guidelines
concerning security and data protection.
Multi-user and simultaneous data entry.
Intuitive friendly web forms.
Compatible with Windows / SQL Server and Linux / MySQL and with main browsers
(Internet Explorer, Mozilla Firefox, Google Chrome, Safari and Opera).
Advanced user profiling management and customization.
Source-verified data locking at visit / page / single variable level.
On-line control of data plausibility and consistency.
Automatic query generation.
Double data entry management.
Production of blank and annotated CRF.
Use of ad hoc medical dictionaries (MedDRA, WHO, etc).
Exporting data to SAS and Excel format.
Graphic reports and descriptive statistics.
Secure data transmission using 256-bit SSL (HTTPS) protocol.
Certificate for data encryption acquired from Thawte Certification Authority.
User authentication throughout complex personal password.
Session timeout after 20 minutes inactivity.
Hosting server in a secure web farm under 7x24 monitoring.
Redundant daily backup.
Audit Trail: tracking all user operations (e.g. visited pages);
user data audit, patients and centres audit, CRF data audit.
eCRF Data Entry
Patients Data Report
Audit for all chagnes