External Release Notes: eTMF v8.0 (December 20, 2024)
We are pleased to announce the eighth major release of the eTMF application, which allows users to store and manage unblinded documents within Egnyte eTMF.
New Features and Enhancements
Assign a Blinding Designation to Study Artifacts (Limited Availability)
- Users with permission to edit the Artifact Configuration page of Study Configuration may now leverage a new Unblinded column to indicate whether documents uploaded to a given artifact may contain unblinded content.
- Users without Unblinded Access can never access documents associated with an unblinded artifact.
Grant Users Unblinded Access Independent of Other Permissions (Limited Availability)
- The Study Configuration Permissions tab now contains an additional permission called Unblinded Access.
- Users may view and edit unblinded documents (documents classified to an artifact with a blinding value of “unblinded”) when they are assigned the Filing Level Unblinded Access role in addition to their other permissions.
- All Administrators have Unblinded Access permissions which cannot be modified.
View the Configure User Roles and Groups for the eTMF App article for more details.
Contact a Customer Success Manager or the Egnyte Sales team for more details on these features.
Audit Enhancements
We have also introduced additional enhancements to eTMF audit logging. Specific improvements include:
- Adding Group Names to the existing Group IDs for eTMF level permission updates.
- Additional depth in the recording of initial values upon creation of an eTMF and study level configuration properties.
- Correcting reporting of “previous value” information when updating trial level permissions.
Note to customers with active eTMFs prior to the specified release date: This correction pertains solely to the previous value of trial level permissions. Historical new value data related to changes to trial level permissions remains accessible and unobscured. Therefore, we recommend utilizing the new value data within the eTMF audit reports to present a chronological history of trial level permission changes prior to this release.
Additional Information and Resources
The current release contains a few improvements to existing functionality.
- Minor performance, security and stability improvements
- Minor logging and UI improvements
- Minor bug fixes