Binder vs Viewer
eTMF provides two ways to find documents by the reference model, with different roles:
| Binder | TMF Viewer | |
|---|---|---|
| Role | Physical filing container of the Master File | Virtual view computed from DocType → Artifact mapping |
| Creation | Requires Create Study Binders; supports Auto-Filing / manual links | Independent of whether Binders exist |
| Content | Section tree → document links (with Filing Origin) | Artifact tree + document list, computed by Study scope |
Moving documents in or out of a Binder does not change their position in the Viewer; Viewer positions depend only on document classification and Study scope.
Creating Study Binders
- Open the study → All Actions → Create Study Binders.
- Select the Model (e.g. TMF RM v3.0) and Filing Levels (study / country / site level master files), then confirm.
- After creation you'll see a Study Level File, Country Level File, and Site Level File (for existing countries/sites).
Note
Creating again when a same-level Binder already exists is idempotent (may count as skipped).
Auto-Filing
Approved documents whose classification maps to the current Model are linked into the corresponding Section node with Filing Origin = Auto-filed:
- Country/site-level documents only land in the matching level's Binder; they do not fall back to Study Level.
- If the tree is empty, wait a few seconds and refresh; otherwise run Refresh Auto-Filing.
- Repeated refreshes do not create duplicate nodes.
Using the TMF Viewer
- Top navigation → TMF Viewer.
- Select the Study; choose the View Model (ideally the same Model used for Binders).
- Expand the Artifact tree on the left to locate documents; click a document in the right list to open its detail page.
- Select Study Country / Study Site to scope the view; Collapse All / Expand All controls tree expansion.
Note
If the Viewer tree is empty: verify a Study is selected and documents have a Classification mapped to the current View Model.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Approved documents missing in the Binder tree | Verify the matching-level Binder exists, the Model's Artifact mapping covers the DocType, wait for the job, or run Refresh Auto-Filing |
| Refresh Auto-Filing changes nothing | Verify document Study / Country / Site exactly match the Binder level, and Classification maps to the Binder's Model |
| New uploads not visible in the Viewer | Verify Document Type / Classification maps to the TMF RM and the document's Study field is correct |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Tab | TMF Viewer: View | Accessing the TMF Viewer |
| Object | Document: Read | Browsing and opening documents |
| Object action | Study: Create Study Binders | Generating Master File Binders |
| Object action | Binder: Refresh Auto-Filing | Manually triggering auto-filing |
Read-only roles such as External Inspector can use the Viewer fully (virtual browsing does not depend on Binders); creating Binders and refreshing filing require edit-class permissions.