| name | clinical-trial-tracker |
| description | Designs clinical trial monitoring dashboards and tracking frameworks for enrollment, protocol adherence, safety reporting, and regulatory milestones. Outputs a trial tracking specification with KPIs and alert thresholds. |
| allowed-tools | Read, Write, WebSearch |
| effort | high |
Clinical Trial Tracker
When to activate
When setting up monitoring for a new clinical trial, when an existing trial has enrollment or protocol deviation concerns, or when preparing for a regulatory audit or DSMB review. Use for Phase I-IV trials across all therapeutic areas.
When NOT to use
Skip for pre-clinical (animal) studies (use bio_research_stack), retrospective chart reviews without prospective tracking, or when the trial monitoring framework is already operational and meeting all KPIs.
Instructions
-
Trial design parameters:
- Phase, therapeutic area, primary endpoint
- Number of sites, target enrollment, timeline
- Key inclusion/exclusion criteria
- Randomization scheme and blinding
-
Enrollment tracking:
- Screened vs. enrolled vs. target (by site)
- Screen failure rate and reasons
- Enrollment velocity (patients/week) vs. plan
- Diversity metrics (race, ethnicity, sex, age)
-
Protocol adherence:
- Deviations: Major (affect safety/data integrity) vs. minor
- Deviation rate per site, trend over time
- Common deviation types and root causes
- Corrective and preventive actions (CAPA)
-
Safety monitoring:
- SAE reporting: Count, relatedness, expectedness
- SUSAR reporting timeline (7 or 15 calendar days)
- DSMB review schedule and data packages
- Stopping rules and futility boundaries
-
Regulatory milestones:
- IND/NDA/BLA submission timeline
- FDA/EMA meeting dates (Pre-IND, End-of-Phase 2)
- IRB/EC renewal dates per site
- Informed consent version tracking
Output Format
TRIAL TRACKER: [Protocol ID] — [Title]
PHASE: [I/II/III/IV] | THERAPEUTIC AREA: [area]
PRIMARY ENDPOINT: [endpoint] | TARGET ENROLLMENT: [N]
ENROLLMENT DASHBOARD:
| Site | Screened | Enrolled | Target | Screen Fail % | Velocity |
|------|----------|----------|--------|---------------|----------|
PROTOCOL DEVIATIONS:
Total: [X] | Major: [X] | Minor: [X]
Rate: [X] per 100 patient-visits
Top types: [list]
SAFETY:
SAEs: [X] | Related: [X] | SUSARs: [X]
Deaths: [X] | Discontinuations (AE): [X]
REGULATORY MILESTONES:
| Milestone | Planned | Actual/Forecast | Status |
|-----------|---------|-----------------|--------|
ALERT THRESHOLDS:
Enrollment: <[X] patients/week → escalate
Screen fail: >[X]% → review criteria
Deviations: >[X] per site → monitoring visit
SAE: Report within [X] hours of awareness
Example
TRIAL TRACKER: PROTOCOL-2026-042 — Phase III Anti-PD-1 in Metastatic NSCLC
PHASE: III | THERAPEUTIC AREA: Oncology (NSCLC)
PRIMARY ENDPOINT: Overall survival (OS) | TARGET ENROLLMENT: 600
ENROLLMENT DASHBOARD:
| Site | Screened | Enrolled | Target | Screen Fail % | Velocity |
|-------------|----------|----------|--------|---------------|-----------|
| MD Anderson | 89 | 52 | 60 | 42% | 3.2/week |
| Mayo Clinic | 67 | 38 | 45 | 43% | 2.8/week |
| UCLA | 45 | 21 | 40 | 53% | 1.5/week |
| Total | 312 | 178 | 600 | 43% | 8.1/week |
PROTOCOL DEVIATIONS:
Total: 23 | Major: 4 | Minor: 19
Rate: 2.1 per 100 patient-visits
Top types: Missed imaging window (8), dose modification without documentation (5)
SAFETY:
SAEs: 34 | Related: 12 | SUSARs: 3
Deaths: 8 (5 disease progression, 2 infection, 1 unknown)
Discontinuations (AE): 14
REGULATORY MILESTONES:
| Milestone | Planned | Actual/Forecast | Status |
|---------------------|------------|-----------------|---------|
| FPFV | 2025-09-01 | 2025-08-28 | ✅ Done |
| Interim analysis | 2026-06-01 | 2026-07-15 | ⚠️ Delay|
| DSMB review #3 | 2026-08-01 | 2026-08-01 | On track|
| LPLV | 2027-03-01 | 2027-06-01 | ⚠️ Risk |
ALERT THRESHOLDS:
Enrollment: <6 patients/week → escalate (CURRENT: 8.1 ✅)
Screen fail: >50% → review criteria (CURRENT: 43% ✅, UCLA 53% ⚠️)
Deviations: >5 per site → monitoring visit
SAE: Report within 24h of awareness
