Site coordinators managing Phase II oncology trials were drowning in disconnected spreadsheets and missing adverse event windows. This is the UX process behind a unified patient monitoring system that cut protocol deviation reporting time by 34% and improved AE response rates to 97%.
Before any wireframes, I spent two weeks embedded with site coordinators and two PIs at a Phase II oncology trial site. The system in use was a combination of a legacy EDC (electronic data capture) tool, a shared Excel tracker, and a physical binder of protocol amendments. The design problem wasn't a missing feature — it was a missing model of how the work actually happened.
| PRINCIPLE | IN PRACTICE | PRIORITY |
|---|---|---|
| Surface risk, not data | The dashboard opens to what needs attention today — not an alphabetical patient list. Triage is the system's job, not the coordinator's. | Critical |
| AE windows are non-negotiable | Adverse event reporting deadlines are regulatory requirements. They get primary visual treatment — always visible, never buried in a detail view. | Critical |
| Two personas, one surface | No role switching. Coordinators and PIs see the same interface — coordinators drill down into tasks; PIs read the summary layer without context-switching. | High |
| Audit everything | In a regulated clinical environment, every action — including a read — is potentially auditable. The design must make this invisible to users but complete for compliance. | High |
I mapped four flows: the coordinator's daily triage, the AE escalation path, the PI's weekly review, and the deviation reporting workflow. The deviation flow had the most friction and the highest regulatory stakes — it became the first prototype target.
| LAYER | WHAT IT CONTAINS | WHEN VISIBLE | DESIGN TREATMENT |
|---|---|---|---|
| L1 · Status | Patient ID, current visit, enrollment status, AE flag, last contact | Always — in table row | Full width, sorted by risk tier, color-coded left border |
| L2 · Events | Active AEs, open deviations, upcoming visit windows, pending forms | On row click — slide-in panel | 300px panel, non-modal, preserves table context |
| L3 · History | Full visit log, prior AEs, lab trends, consent versions | On explicit request — new view | Full-screen patient record; intentional navigation cost |
Clinical software has an earned reputation for visual chaos — dense tables, inconsistent status colors, no hierarchy. I built the token system before touching a single component, with a specific constraint: every status color had to be WCAG AA compliant at the background values used in the product, and every semantic color had to carry only one meaning across the entire system.
Production-fidelity prototype of the Site Coordinator Dashboard. Click any patient row to open the detail panel. Use the filter controls to triage by status. The AI flag system, status chips, and detail panel all work as they would in the shipped product.
The prototype was validated in a two-week usability study with 6 coordinators at the original trial site. Measurements were taken against the existing EDC + Excel workflow. Three metrics were defined before the study began — no post-hoc cherry-picking.
| FEATURE | WHY CUT | FUTURE STATE |
|---|---|---|
| AI auto-grading of AEs | Coordinators need to own the CTCAE grade — automated grading created liability ambiguity and eroded trust faster than it saved time. The AI flags; the human grades. | V2 — AI as suggestion with explicit override |
| Real-time lab value charts | Coordinators don't act on trends — they act on thresholds. A sparkline adds cognitive load without triggering different behavior. The threshold flag is enough. | Available in L3 patient history view only |
| Cross-site comparison dashboard | PIs found it interesting but couldn't act on it in a single-site context. Built a better single-site tool first; multi-site is a logical v2 with sponsor access controls. | V2 — requires sponsor-level permissions design |