The Three-Level Taxonomy
Document Type is the master data for the TMF document taxonomy, in a Type → Subtype → Classification hierarchy:
| Level | Meaning | Example |
|---|---|---|
| Type | Top-level category | Regulatory, Safety Reporting |
| Subtype | Division under a type | Regulatory → Reports |
| Classification | Finest category | General → Relevant Communications |
Each entry marks its level with the Level field and hangs under its parent via the Parent Type self-reference, forming the taxonomy tree. The taxonomy feeds the type/subtype/classification triple referenced by EDL templates, and it is the matching basis for automatic document filing.
Seeded Document Types
The product ships 11 top-level Types (plus a platform-level General), each with a document number prefix:
| Type | Number format |
|---|---|
| Regulatory | REG-{####} |
| Safety Reporting | SAF-{####} |
| Trial Management | TM-{####} |
| Site Management | SITE-{####} |
| Data Management | DM-{####} |
| IP and Trial Supplies | IP-{####} |
| IRB or IEC and other Approvals | IRB-{####} |
| Central Trial Documents | CTD-{####} |
| Central and Local Testing | CLT-{####} |
| Statistics | STAT-{####} |
| Third Parties | TP-{####} |
Subtypes and Classifications are seeded as well (e.g. Regulatory → Reports, Data Management → Database/Data Capture).
Document Numbering
A Type carries a Document Number Format and Start Number; documents of that type are numbered sequentially from it. When creating a new Type, configure both so documents never lack a numbering rule.
Mapping to Reference Model Artifacts
Each taxonomy entry can map to TMF reference model artifacts:
| Field | Meaning |
|---|---|
| eTMF RM v2.0 / eTMF RM v3.0 | Maps to an artifact of TMF RM v2.0 / v3.0 |
| Vault Clinical Docs | Maps to a Vault Clinical Docs artifact |
Once mapped, documents can be browsed by reference model hierarchy in the TMF Viewer, and the Binder Section to Document Type model files documents by matching Type/Subtype/Classification to binder section names (see Models & Artifacts).
Use in EDL Templates
Template Expected Documents entries reference this taxonomy through the Type / Subtype / Classification fields, and study-side EDL Items inherit the same classification (see Template EDLs & Template Expected Documents). Changing the taxonomy affects every template and existing study that references it — assess the impact before changing.
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Document Type: Create, Read, Edit | Maintaining the taxonomy tree and numbering rules |
Clinical Application Administrator maintains the taxonomy; Document Contributor is read-only.