Overview
The TMF Homepage is the daily entry point for study health, visualizing the timeliness, completeness, and quality of your TMF documents, plus tasks and milestones. At the top, the Study selector: Study is required, Study Country / Study Site are optional and scope the metrics down to a country or site.
Widget Overview
| Widget | Shows |
|---|---|
| Completeness | Completeness percentage + Unapproved Documents count |
| Timeliness | Approval timeliness pie chart (threshold days configured by an admin) |
| Upcoming Milestones | Milestones without an Actual Finish Date, filterable by Milestone Category |
| Quality Issues | Quality issue pie chart, filterable by Open / Closed / All |
| My Tasks | Up to 10 tasks assigned to me |
| Tasks Requiring Attention | Overdue / Unassigned / Due Today counts |
Completeness Semantics
- The percentage is based on EDL Items with Requiredness = Required under the selected milestone.
- Unapproved Documents: count of documents you can view whose latest version is not steady state (excluding Superseded / Obsolete); clicking opens the pre-filtered document list.
- Review Overcount: jumps to EDL Items with Overcount = Yes.
- Review Pending Decisions: jumps to EDL Items with Requiredness = Pending Decision.
Timeliness
Timeliness tracks how long it takes to approve a document and file it in the TMF. The pie chart splits by threshold (e.g. "approved ≤30 days / >30 days"), configured by an admin under Admin → Settings → Application Settings → eTMF Features.
Quality Issues & Tasks
- Quality Issues groups issues by type (Duplicate / Expired / Misclassified etc.), filterable by Open, Closed, All, or assigned to me. Issues only appear for document types configured with the Quality Issue field.
- My Tasks shows only document, envelope, and clinical user tasks; quality issue tasks are viewed in the Quality Issues widget.
Inspection Readiness Checklist
| Check | Where to look |
|---|---|
| EDL completeness | Completeness percentage |
| Unapproved documents | Unapproved Documents count → click into the list |
| Overcount / pending | Review Overcount / Review Pending Decisions |
| Timeliness | Timeliness threshold semantics |
| Open quality issues | Quality Issues → Open |
| Upcoming milestones | Upcoming Milestones |
| Personal tasks | My Tasks |
Note
If Timeliness shows 0%, there are usually no approved documents yet or no threshold configured; approve a document and refresh.
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Tab | TMF Homepage: View | Accessing the TMF Homepage tab |
| Object | Study / Milestone / EDL Item: Read | Data for Completeness, Upcoming Milestones and other widgets |
| Object | Document: Read | Unapproved Documents count and drill-down |
| Object | Clinical User Task: Read | My Tasks, Tasks Requiring Attention |
| Object | Quality Issue: Read | Quality Issues widget statistics |
The page only shows documents and tasks you have Read access to; data is further scoped by the study hierarchy's dynamic sharing (Team Role + Grant Access).