A training step can now be enabled in Workflows. When training is enabled an approved document can be assigned to users to read and understand. The new Train option is visible on documents as part of workflow options under the Current card.

When a document is routed to users for Training users will receive an email to complete the training including the note defined when Users are selected.

The document will display a Train card that identifies trainees and the training note. Trainees cannot complete the training until the have reviewed the document.

When a user completes the training they can be presented for a reason for completing the training. Reasons can be defined by a Workspace Manager in Settings. Completed trainings, as well as the reason are captured in the audit trail.

This release includes the first round of updates to support significantly expanded functionality for custom meta data in the application. This release does not introduce new metadata fields, but does not include Category (Group and Sub-group) values and Artifact values from the EDM reference model.

Metadata fields can now be defined as Text, Date, Select (Picklist), or Multi-select. Individual fields can also be set as required. Individual fields can also be defined to display in the Current card view in the documents pane.

Future updates will expand functionality to implement the latest metadata field recommendations from the EDM reference model as well as the ability to define custom document types, document categories, and artifacts.

The version view now supports deleting individual Source, PDF, or Redactions from a version.

Individual versions of a document can now be copied to a new document. This is helpful to use an existing document as the starting point for a new document.

To copy a version to a new document click on the Action menu for a version and select Copy to New Document. You will be presented with a modal to select a new document name. The source, PDF, and redaction of the version will be copied to the new document. Metadata for the version is also copied to the new document. The copy is captured in the audit trail of the new document.
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The system now automatically detects if you are uploading a file that already exists in the DMS. Uploaded files have their checksum calculated and compared against existing files. If the checksum matches an existing document the user is alerted. Clicking on the red text will identify the document(s) and location that match the uploaded file.

Investigator users can how have discrete permissions in different locations. This supports the use case of enabling an Investigator to upload documents in specific areas of the TMF for their site while having only read-only access to Central Trial Documents like the Protocol or Investigator Brochure.

A full list of changes will be loaded into your Validation folder in Kivo. Look for the Change Control documentation for release Q1.2023.4.