Release Notes – Illume Server Disk Set version 6.0.18878
When electronic data capture (EDC) is used for an FDA-regulated clinical trial, 21 CFR Part 11 is the regulation that ensures that electronic signatures and electronic records are capable of protecting security, privacy, and the integrity of study data. It’s a good regulation that encourages the transition away from paper-and-pencil forms through the use of reliable computer systems.
The newest version of Illume has officially been validated as 21 CFR Part 11 compliant.
Below is a list of what’s new in the 6.0 compliance product:
- The Survey Manager desktop client may now be accessed directly through the web interface, through a new link in the navigation called “Survey Manager”. The latest version of the survey manager is updated upon launch, so the survey manager will always be up to date. This is done using a Microsoft ClickOnce deployment that is associated to each DatStat install.
- The Require Interviewer option has been added to surveys in the Survey Manager, so that an interviewer login can be required to access surveys where data is being input by a user on the system.
- The Auto Lockout Period application setting has been added. This feature allows configuration of an amount of time, after which an inactive user’s account would be locked.
- Survey sessions may now be locked by users with appropriate permissions. Once locked, a session can no longer be unsubmitted, modified, or deleted. An electronic signature tracks the user who locked the survey as long with a statement of reason for the locking action.
- LDAP username and password have been added as application settings to support authenticated LDAP connections.
- The user’s last login date and time has been added to the product. This time stamp is viewable from all applications within the web interface, as well as in the survey manager.
- Dates are now all displayed in an unambiguous format, including a 3-letter month.
- The Datstatadmin user is created upon upgrade, if it does not already exist.
- Username and password are not saved, and not offered to be saved by the browser on the login screen.
- Administrators now specify temporary passwords for users, rather than new passwords. The user with the temporary password will be prompted to change that password upon next login.
- Only the Administrator user can change their own password
- Auditing now labels survey data manually input by the participant. In the past, the participant was not specified, only the fact that it was collected with an online submission.