Models
A Model is the container of a TMF reference model — for example the DIA TMF Reference Model v2.0 / v3.0. Maintain under Admin Setup → Models:
| Field | Notes |
|---|---|
| Name | Model name (required, unique) |
| Description | Model description |
| Display in TMF Viewer | Whether to show in the TMF Viewer (default yes) |
Five models are seeded:
| Model | Purpose |
|---|---|
| TMF RM v2.0 (2012) | DIA TMF Reference Model v2.0 |
| TMF RM v3.0 (2015) | DIA TMF Reference Model v3.0 |
| Document Type Hierarchy | Browse by document type hierarchy |
| Vault Clinical Docs | Vault clinical documents model |
| Binder Section to Document Type | Auto-filing model: files documents by matching their Type/Subtype/Classification to binder section names |
Artifacts
An Artifact is a node (Zone / Section) inside a reference model, forming the standard TMF hierarchy such as 01 Trial Management → 01.01 Trial Oversight → 01.01.01 Trial Master File Plan. Maintain under Admin Setup → Artifacts:
| Field | Notes |
|---|---|
| Model | The owning model (required) |
| Name | Artifact name |
| Number | Hierarchy number, e.g. 01.01.01 |
| Parent Artifact | Parent artifact; self-reference builds the tree |
| Description | Artifact definition text (from the TMF Reference Model) |
Note
The complete TMF RM v2.0 artifact tree is seeded with official definitions — a standard hierarchy for internal SOPs and inspection readiness.
Relationship to Document Filing
The eTMF RM v2.0 / eTMF RM v3.0 / Vault Clinical Docs fields on Document Type map the taxonomy to artifacts (see Document Types), while the Binder Section to Document Type model matches documents to filing locations by taxonomy. Together they auto-file documents to their reference-model location after save and make them browsable by model-artifact hierarchy in the TMF Viewer (see TMF Viewer).
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Model / Artifact: Create, Read, Edit | Maintaining reference models and the artifact tree |
Models and artifacts are system-managed master data, seeded out of the box; Clinical Application Administrator may adjust them, Document Contributor is read-only.