Whether your organization uses the Model and Artifact objects to reflect the TMF Reference Model, to support auto-filing for Study Startup binders, or both, this article will help you understand how to configure and work with these objects.
Note: This feature is only available on Clinical Operations eTMF and Clinical Operations Study Startup Vaults.
About the Filing Model
Users can define Filing Model on both binder templates and individual binders. This field instructs Vault to use specific auto-filing behaviors.
- Binder Section to Document Type: This supports the pre-V13 auto-filing behavior, wherein the name of the document type must match the name of the binder section.
- TMF RM 2.0, TMF RM 3.0. etc.: This uses a match of the artifact mapped to a document type to the artifact (zone/section) mapped to a binder section to drive auto-filing.
- Vault Clinical Docs: This uses a match of the artifact mapped to a document type to the artifact mapped to a binder section to drive auto-filing. The auto-filing logic is different from that used with TMF RMs.
Note that although you can add this field to other document types, auto-filing will only work on binders with certain document types:
- For TMF RM or Binder Section to Document Type filing models: Trial Master File, Country Master File, and Site Master File (eTMF Vaults created before V10) or Study Level File, Study Country Level File, and Study Site Level File (newer Vaults)
- For Vault Clinical Docs filing model: Study Start-Up Packages or any custom subtypes/classifications under this document type
About Model & Artifact Document Fields
There are several shared document fields associated with Model and Artifact objects:
- Model: By default, this shared field is not associated to any document types. When you add it to document types, it will simply show users what models are associated (via the document type configuration) with each document. On documents, this field value will not be editable.
- Artifact: By default, this shared field is not associated to any document types. When you add it to document types, it will show users what artifacts are associated (via the document type configuration) with each document. On documents, this field value will not be editable.
How to Add the Artifact Field to Document Types
For auto-filing to work correctly, you must associate the standard, shared Artifacts field with any document types, subtypes, or classifications that should auto-file into binders. Learn how in Working with Shared Fields.
How to Associate Document Classifications to Artifacts
When you associate artifacts to a document classification, you define field values for documents with that classification. This behavior does not work like other field defaulting. Firstly, Vault updates the fields on existing documents whenever the document type setting updates, rather than only during initial document creation. Secondly, these fields are read-only for all users, meaning that the values Vault auto-populates are read-only. Vault uses these document fields to facilitate binder auto-filing.
To assign an artifact to a document classification:
- Navigate to Admin > Configuration > Document Types and open the details dialog for a specific classification.
- In the Type Defaults tab, under Reference Models, select an artifact for each reference model.
- Click Save.
Although these settings are available at any level in the document type hierarchy (Base, Type, Subtype, or Classification), only the Classification level is relevant for most eTMF customers.
How to Associate Document Classifications to Subartifacts
Subartifacts further refine the Classification of a document through the Subartifact document field, which negates the requirement for a separate Classification for TMF Reference Model subartifacts.
Enabling Subartifact Document Fields
To enable Subartifact document fields:
- Navigate to Settings > Application Settings > eTMF Features > Enable Subartifacts.
- Click Edit.
- Select the Enable Subartifacts checkbox.
- Click Save.
Assigning Subartifact Objects to Document Classifications
To assign a Subartifact object to a document classification:
- Navigate to Business Admin > Objects > Subartifacts.
- Click Create.
- In the Details section, name the Subartifact and set the status to Active.
- Assign a Document Classification for the Subartifact.
- Click Save.
Assigning Subartifact Objects to EDL Item Templates
EDL Items include a Subartifact field where the subartifact is defined. When this value is populated, Vault matches the EDL item to the document that matches on both the Classification and Subartifact, along with other matching criteria that may be applied.
- Navigate to the EDL Item Template object, either through a custom tab or in Business Admin > Objects > Template EDLs.
- Click Create.
- Fill the required fields and add Subartifact to the Matching EDL Item Fields.
- In the EDL Item Template Detail Page Layout, add the Subartifact field.
- Click Save.
Note: To enable Subartifacts for Expected Document Lists, Admins must add Subartifacts as a matching field.
How to Associate Binder Template Sections to Artifacts
By associating binder sections to a specific artifact (zone or section), you enable Vault to auto-file documents into a binder that properly uses the TMF RM structure.
To assign an artifact to a section in a binder template:
- Navigate to Admin > Business Admin > Templates: Binders & Documents.
- In the Template Location panel, select a document type.
- Open a specific binder template.
- Under Details, click Edit.
- Select a Filing Model.
- Click Save.
- Under Binder Structure, click Edit.
- For each binder section, select Edit from the Actions menu. If you’re using one of the TMF RM options for Filing Model, select a specific artifact in the Hierarchy Mapping field. This list automatically filters to show only artifacts associated to the filing model.
- Click Save when finished.
When you associate binder sections in a template to specific artifacts, Vault can only apply these mappings to binders created after saving the template changes. Any binders that were already created using the template are not affected. See below for details on editing section mappings for existing binders.
How to Associate Binder Sections to Artifacts
By associating binder sections to a specific artifact (zone or section), you enable Vault to auto-file documents into a binder that properly uses the TMF RM structure. If a binder was created from a template with the correct filing model and artifact mappings, you do not need to edit sections within individual binders. However, Vault allows you to select a different filing model and artifact mappings on individual binders for situations where a binder was created from a template that is not correct.
To assign an artifact to a section in an individual binder:
- Open the binder.
- In the document fields panel, click Edit.
- Select a Filing Model.
- Click Save.
- Click Edit Binder and open the Outline View for the binder.
- For each binder section, select Details from the Actions menu. If you’re using one of the TMF RM options for Filing Model, select a specific artifact in the Hierarchy Mapping field. This list automatically filters to show only artifacts associated to the filing model.
- Click Done Editing when finished.