TMF Transfer

Your Clinical Basics Vault is set up to receive TMF Transfers of closed studies from your CRO’s Vault. This guide outlines the preparation and execution process.

Preparing for a TMF Transfer

Successful TMF transfer requires careful coordination with your CRO. Use the following checklist to ensure all requirements are met before initiating the transfer.

Phase 1: CRO & Vault Readiness

First, confirm with your CRO if they have completed a Vault-to-Vault TMF Transfer before.

  • If yes, the Vault is ready. You can proceed.
  • If no, ask if the TMF Transfer functionality is enabled in the Vault.
    • If the functionality is configured, you can proceed.
    • If it’s not configured but they plan to enable it, what is the estimated date?
    • If they do not plan to configure the functionally (or within a timeframe that meets your needs), you will need to proceed with a traditional migration.

Phase 2: Vault Licensing & Study Scope

Ensure your Vault is licensed to handle the incoming data.

Note Licensing is only enforced in your production Vault. Your sandbox Vault can exceed the license count for testing purposes.
  • Number of studies to be transferred.
  • Number of sites transferred for each study (and of these, number of sites Not Selected).
  • Confirm that all studies to be transferred are closed and ready for archival.
  • Number of archived site licenses available in your production Vault (check under Admin > About).
  • Based on the above, how many additional archived licenses are needed (notify AP)?

Phase 3: Data & Metadata Alignment

Only standard data and documents in specific states are included in the transfer.

Important Only documents in an Approved or Superseded steady-state are included in the transfer. Documents in other states (like In Review or Draft) will be excluded.
  • Has the CRO confirmed if they are using any additional criteria to exclude documents?
  • Have you obtained a TMF Inventory Report from the CRO that only includes documents that will be part of the transfer? This will be crucial for QC later.
    • This report can be compared against the Transferred Documents report in Vault when performing a QC of the transfer.
      Note Because the Library stacks Superseded documents under Approved ones, its document count will not match the Inventory Report. For an accurate comparison, use Vault’s Transferred Document report, which aligns with the inventory by listing each version on its own line.

Document Metadata
Only standard metadata fields are transferred to Basics.

  • Document Name
  • Document Date
  • Classification
  • Version
  • Study, Study Country, Study Site
  • Additional Information
  • Person (*on specific document types)
  • Product
  • Source Document Number

If your CRO is using any custom fields in lieu of the above standard fields, they will need to be mapped ahead of the transfer.

  • Does the CRO use all required standard fields, requiring no mapping?
  • If mapping is needed, has the mapping plan been established?

Phase 4: Team & Timeline Coordination

Use the following to plan your team’s preparedness for the TMF transfer:

  • Have you created Vault Admin accounts for all team members who will perform or QC the transfer?
  • Who is the primary CRO contact responsible for performing the transfer?
  • When is the scheduled date for the test transfer into your Basics sandbox Vault?
  • What is the timeline for your internal team to complete the QC of the sandbox transfer?
  • When is the scheduled date for the final production transfer?
  • Have you obtained the Connection File from your CRO?
  • Has your team reviewed the TMF Transfer work instructions to understand the process?

Performing the TMF Transfer

Once preparation is complete, track the execution of the transfer itself.

  • Sandbox TMF Transfer Complete
  • Sandbox TMF Transfer QC Complete & Approved
  • Production TMF Transfer Complete