Vault Study Startup customers use binders to organize key study documents like country adaptations/translations or regulatory and ethics filings at the country/site level. To support the heavy reuse of key documents that is typical for study start-up submissions, Vault Study Startup has flexible rules for auto-filing documents into binders.

Note that Study Startup is a separate application that is available alone or on an eTMF Vault.

Study Startup Auto-Filing Logic

Whereas TMF auto-filing only matches a document with a single binder, Study Startup auto-filing may add a single document to hundreds of binders. In TMF auto-filing, documents file into the lowest-level binder possible: If only the Study field is populated, the document goes into the study-level binder. If the Study Country field is populated, the document goes into the study country-level binder.

Study Startup auto-filing adds documents to the lowest-level binder possible, but can also file documents into lower-level binders. Study Startup applies a “best available” matching method: for any given artifact, Vault adds the document that matches at the same level as the binder level, if it is available. If this binder doesn’t exist, Vault adds any documents that match at the next highest level, up to the Study level.

Matching Example

A Vault contains two protocol documents for a single study:

  • “Protocol Master” has only the Study field populated.
  • “Protocol US” has the Study and Study Country (US) fields populated.

The Vault also contains three binders for the study:

  • “Study 301 Binder” is at the Study level.
  • “US Study 301 Binder” is at the Study Country level, for the US.
  • “Canada Study 301 Binder” is at the Study Country level, for Canada.

“Protocol US” would file into “US Study 301 Binder” only, but “Protocol Master” would file into “Study 301 Binder” and “Canada Study 301 Binder”. The latter occurs because, for Canada, there is no protocol document at the country level.

If a user later created a “Protocol Canada” document and refreshed auto-filing on the “Canada Study 301 Binder,” Vault would remove “Protocol Master” and add “Protocol Canada.”

About Filing Model

For Study Startup auto-filing to work, the binder’s Filing Model field must be set to Vault Clinical Docs. Vault then matches documents to specific binder sections based on 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.

Define the Filing Model on your binder templates and individual binders.

How to Trigger Auto-Filing

Vault automatically adds and removes documents from binders when users create or reclassify those documents. However, Vault does not trigger auto-filing automatically when users edit the document or binder field values that auto-filing uses. To trigger auto-filing for a specific binder, you can choose Refresh Auto-Filing 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. Vault cannot remove documents from a binder if they are version-bound, or if a user manually added the document to the binder.

To refresh auto-filing for a binder that allows this action, you must have the Edit Document permission on that binder.