IDAS is a web-based system for collecting and managing CRF data, using a standard web browser.
MAIN FEAUTURES
- 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 main browsers: Chrome, Firefox, Internet Explorer and Safari.
- Advanced user profiling management and customization.
- On-line randomization.
- Source-verified data locking at visit / page / single variable level.
- On-line control of data plausibility and consistency.
- Automatic query generation.
- E-monitoring tools.
- 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.
SECURITY
- 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 hardware.
- Redundant daily backup.
- Audit Trail: tracking all user operations, user data audit, patients and centres audit, CRF data audit.
