Creating TMF Export Packages

When configured, the TMF Export feature allows you to create transferable packages of TMF documents, metadata, and audit trails for individual Study records. These packages simplify sharing study data with Sponsors and organizations, particularly those not using Veeva eTMF.

Generating a TMF Export Package

When configured, you can generate a TMF Export Package from a Study record by selecting the Export TMF Package action. Once you select the action, a dialog opens where you can refine the scope of the export with the following fields:

  • Export Configuration: Select a TMF Export Configuration template to populate default settings.
  • Lifecycle States: Select the document states to include in the export package.
  • Content Options: Choose whether to include unblinded content, source files, renditions, or document attachments.
  • Audit Trails: Select whether to include an audit trail CSV file for each document in the export.

Once you select OK, Vault initiates two jobs: TMF Export Setup and TMF Export Upload. The jobs run asynchronously and can be canceled by an Admin at any time during the job’s run.

Vault generates the export package based on the permissions of the user who initiated the action. This ensures that the package only includes documents the user is authorized to view.

About Export Packages

Once Vault successfully generates the TMF Export Package, you can access your export on the File Staging Server.

Export packages contain the following files:

  • Document Files: These files include all applicable versions, renditions, and attachments.
  • Document Listing (CSV): A readable file containing document metadata and relative folder paths for every file in the package.
  • Document Audit Trails: If selected, the export includes a CSV file for each document containing its full audit history.
  • Failure Log: The failed_documents.csv file lists any documents that could not be exported and the reason for failure.

The zipped export package remains available on the File Staging Server for two weeks before being automatically deleted.

Export Package Folder Structure

Export packages are organized in folders based on the TMF 3.0 Reference Model: Study + Export JobID > Filing Level > Study Country > Site > Zone > Artifact > Document

Vault truncates file names in the export package folder structure, ensuring consistency and predictability. Vault applies the following truncation rules based on the folder structure level:

  • Study: Truncates name at 20 characters.
  • Study Country: Uses the two-character code, when available. If blank, Vault uses the three-character abbreviation. If the code and abbreviations are blank, Vault uses the country name and truncates the name at 20 characters.
  • Study Site: Truncates name at 20 characters.
  • Zone: Vault uses the Reference Model mapping Number value. For unmapped documents, Vault uses the Unmapped value.
  • Artifact: Truncates name at 56 characters.
  • Document Name: Truncates name at 40 characters.
  • Rendition Type: Truncates name at 15 characters.