This release includes a series of improvements to backend infrastructure and bug fixes as well as a series of new features related to eTMFs.
Closing Studies
Workspace Managers can now "close" eTMF cabinets. Closed cabinets (or studies) are used when all content has been received for a study and it is ready to "lock" and prepare for long term storage. Closing a cabinet performs the following operations:
All permissions are removed from the cabinet or children folders or documents
Only read-only and inspector permissions can be applied to a cabinet
All documents are locked
A cabinet cannot be closed if it contains:
draft documents
placeholders that are not excluded
open collaborations (edits, collaborations, reviews, or approvals)
or if the cabinet includes aliases
Data Integrity Checks
If a cabinet is closed it will be added to a quarterly data integrity check report that runs automatically every 3 months. This check verifies that the file located in cloud storage has the same checksum as the document when the study was closed. A change in checksum could indicate that the file was corrupted during storage and ensures that Kivo support can verify and potentially correct any data integrity issues from backups.
Document Alias Conversion
Document Aliases can now be converted into a separate stand alone document. This feature is designed to be used in conjunction with closing a study. For example, if a Protocol was authored in the regulatory cabinet and an alias was created in an eTMF you could convert the eTMF alias into a separate document so that they study could be closed and no new versions of the alias would appear in the closed cabinet. When an alias is converted to a separate document the new document maintains the versions that were included in the alias (e.g. all versions, approved versions, or a specified version) as well as the audit trail entries from the source document.
Improvements to eTMF migration
This release includes a host of improvements to the eTMF migration tool.
Improvements in the migration tool UI to show document count and other metrics
Migration output report
Improvements to mapping options to generate cabinet structures in Kivo from Veeva binders
Ability to update import country and site for an import after the initial creation
Ability to map folder paths by TMF reference model IDs
Improved segmentation of audit trail entries between Kivo and Veeva initiated actions
Performance improvements
A full list of changes will be loaded into your Validation folder in Kivo. Look for the validation documentation for release 2023.Q3.3.