Each time a Study Manager successfully publishes the Study Training Matrix via the Study Training Matrix Builder, Vault can automatically generate a historical “version” of the matrix’s current structure as an uneditable PDF Vault Library document.
Note: This feature must be configured by a Vault Admin in Study Training Vaults.
Use Cases
Study Training Matrix snapshots can be used to file matrix information in the eTMF for compliance and auditing purposes, as well as for general historical reference for Study Managers: Each snapshot functions as a matrix “version” that displays exactly how the matrix records were set up at a specific point in time.
How Study Training Matrix Snapshots Work
Each time a Study Manager successfully publishes the Study Training Matrix via the Study Training Matrix Builder, Vault automatically generates a historical “version” of the matrix’s current structure as an uneditable PDF Vault Library document. Snapshots comprehensively capture all records present in the live matrix at the time of publication and include:
- A cover sheet with the Study Number, publication date and time, and the name of the user who published the matrix.
- Landscape-formatted pages with columns matching the ordering and coloring of the Study Training Matrix Builder UI.
- Document fields to easily locate snapshots in the Vault Library, such as the Study.
To do this:
- The first time a matrix is published, Vault files the snapshot under the Training Matrix Snapshot document type v1.0 in the Approved state with specific field values, such as name (
{Study Number} - {Publish DateTime} - Training Matrix Snapshot), the Study with a link to the current matrix, and the Finalize Job ID indicating the Finalize Matrix SDK job run in which Vault created the snapshot. - For each subsequent publication, Vault updates the
{Publish DateTime}value and up-versions the existing snapshot to the next major version (2.0, 3.0, etc.).
Configuration Overview
To configure Study Training Matrix Snapshot:
- Ensure the Training Matrix Snapshot document type is active and assigned to a single document lifecycle (Draft to Approved) only.
- Within the Draft to Approved document lifecycle’s Approved state, update the existing Create Related Training Requirement entry action to exclude the Training Matrix Snapshot document subtype (“If type does not include…Training Matrix Snapshot”). This configuration ensures Vault does not automatically create requirements for snapshot documents.
- Review your Vault’s security configuration and ensure users working with Vault-generated snapshots are assigned the appropriate permissions.
Limitations
- Vault generates snapshots in PDF format only.
- Vault files snapshots in the Vault Library under the Training Matrix Snapshot document type only.
- This type must minimally be active and assigned to a single document lifecycle (for example, Draft to Approved) with a configured Steady State (Approved). Otherwise, Vault cannot publish nor generate a snapshot of any new (v1.0) study matrices.
- Users cannot manually create, update, or delete drafts under this type, as it is strictly Vault-managed. This includes uploading new draft versions, renaming, and reclassifying.
- By default, the Study Training Matrix Builder orders roles, sections, and requirements within sections alphanumerically. However, users may notice discrepancies between the builder UI and PDF snapshot when at least one character used to break ties between two similarly-labeled components is a non-alphanumeric character, such as punctuation or another special character.
Related Permissions
Users working with Vault-generated snapshots must be assigned a document role with View Document and View Content permission in the target document lifecycle’s Steady State type (the Draft to Approved lifecycle’s Approved state).