External Release Notes: eTMF v 11.0 (August 11, 2026)
New Features and Enhancements
Create a New Study from an Existing Study Template
Users with permission to create studies, such as Study Managers and Administrators, will now see an option to duplicate configuration from an existing study when creating a new study. After checking this option and selecting a source study, users may choose to duplicate country/site configuration and/or artifact configuration.
All study creation and configuration duplication activity will be captured in the audit log.
Delete Inactive Countries and Sites
Study Managers and Administrators may now delete inactive countries and sites from a study's configuration. A new Delete option is available from the status drop-down on the Country or Site configuration page. Countries and sites can only be deleted if they contain no associated documents.
Add GXP-Approved Documents Directly to eTMF
Users viewing an approved document in GXP Collaborate can now upload it directly to eTMF without the need to first download and re-upload the file manually. A new Upload to eTMF option is available from the Download Approved Document menu in the Collaborate document viewer.
When uploading via this flow, the document's approval page including all signatures will be automatically appended to the file added to eTMF, ensuring a complete chain of custody is maintained. The document will be added as a Draft, consistent with the standard eTMF upload behavior.
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