You can use binders to organize TMF documentation in your eTMF Vault. Once a binder exists, Vault automatically places documents into matching binders using the Document Type, Study, Study Country, and Study Site fields.
Documents file into the lowest-level binder possible: If only the Study field is populated, the document files into the related Study Master File binder. If the Country field is also populated, the document files into the related Country Master File. Likewise, populating the Site field causes the document to file into the related Site Master File.
Note that in Vaults created after V10, the document types for TMF binders are Study Level File, Study Country Level File, and Study Site Level File.
About Filing Model
Depending on the binder’s filing model, Vault may match documents to specific sections based on:
- Matching the document type label to the binder section name
- Matching the document type’s artifact mapping to the binder section’s artifact mapping
When you update the Filing Model field, Vault automatically deletes any existing Artifact mappings on binder sections. This means that you’ll need to re-map each binder section to the appropriate artifacts to support auto-filing.
Triggers for Auto-Filing
When any of the following document triggers occur, Vault checks the selected study, country, or site and adds the document to the correct binder.
- Document creation
- Document classification
- Document reclassification
- Update to document field values
Users can also manually refresh auto-filing on binders from the binder’s actions menu. This action evaluates the existing contents of the binder as well as any documents not included in the binder, and then adds/removes documents accordingly.
Note that auto-filing always executes on the latest version of a document, even if the document which triggered the auto-filing is not the latest version.
Note: The refresh option is not available if the binder’s Filing Model field is set to Binder Section to Document Type.
A user creates a new document, selects Central Trial Documents > Trial Documents > Investigator Brochure for the document type and then selects VVT485-301 as the study.
Vault checks that a binder exists for study VVT485-301 and automatically adds the new document to the Central Trial Documents > Trial Documents > Investigator Brochure section of the binder.
When users update the Study, Study Country, or Study Site fields for a document that is already filed into a binder, Vault removes the document from its current binder. Note that Vault does not remove a document from a binder if a user manually added the document to that binder or if the document is version-bound in the binder.
For example, Teresa creates a safety report for Site 001 in Study ABC. Vault automatically files the document into the Site Master File 001 binder, and then Teresa also manually adds it to the Study Master File ABC. Later, Teresa changes the document to select Site 002. When she saves, Vault files the safety report into Site Master File 002 and removes it from Site Master File 001. However, Vault does not remove the document’s link to Study Master File ABC because the document was manually added.
Note: Vault considers any document that was filed before the V13 release to be auto-filed.
When you upload or modify a document, you do not need permission on the binder in order for Vault to automatically file the document.
To refresh auto-filing for a binder that allows this action, you must have the Edit Document permission on that binder.