Model and Artifact are standard objects that Vault uses to model the TMF Reference Model (TMF RM), a commonly used standard taxonomy for Trial Master File content. The Model object (model__v
) contains a record for each version of the TMF Reference Model that has been published since 2012. The Artifact object (hierarchy__v
) contains a record for each zone, section, and artifact in each version of the TMF RM.
Unlike other objects, the object data records for Model and Artifact are non-editable and completely maintained by Veeva. As new versions of the TMF RM become available, Veeva will add new Model and Artifact records to all eTMF Vaults.
You can use these object data records in your Vault’s document type configuration to map document classifications to individual artifacts in each version of the reference model. An Admin will perform this analysis and mapping exercise during the initial implementation of your eTMF Vault. Over time, you can revisit these mappings when adding new document types or when a new version of the TMF RM is published.
Vault can use these mappings to drive auto-filing of documents into binders. Each binder template and each binder is associated with a specific Model record using the binder’s Filing Model field. When associated with TMF RM 2.0 or TMF RM 3.0, you can map one Artifact from that version to each section of the binder. Vault uses the combination of Artifact mapping and study fields to auto-file documents into binders.