Clinical Monitoring Plan (CMP) — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-CMP |
| Version | 2.0 (full) |
| Study No. | GLPI103-301 |
| Standard | ICH E6(R3) risk-based monitoring; FDA/EMA RBM guidance |
| Confidentiality | Confidential — TMF |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical Operations | Initial CMP |
| 2.0 | 2026-06-29 | Clinical Operations | Full RBM — KRIs/QTLs with thresholds, SDV plan, visit types |
1. Monitoring Strategy (RBM)
Risk-based monitoring per ICH E6(R3): centralized statistical surveillance + remote review + triggered on-site visits, proportionate to risk, governed by Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs).
2. Critical Data & Processes
Informed consent; eligibility (I/E); randomization integrity & blinding; primary endpoint (HbA1c) source data; SAE/AESI capture & reporting; IMP accountability & compliance.
3. KRIs / QTLs (thresholds)
| Indicator | Green | Amber | Red (action) |
|---|---|---|---|
| Screen-failure rate | <35% | 35–45% | >45% → eligibility/process review (observed 45.0%) |
| Discontinuation rate | <10% | 10–15% | >15% (QTL) → root-cause |
| Missing primary endpoint (Wk 52) | <3% | 3–5% | >5% (QTL) |
| Overdue queries (>30 d) | <5% | 5–10% | >10% |
| AE under-reporting (site vs expected) | within | borderline | outlier → SDV trigger |
| Visit-window deviations | monitor (EDC-005) | — | trend review |
| Protocol-deviation rate | <5% | 5–10% | >10% |
QTL breaches trigger documented root-cause analysis and CAPA (QA-ISSUE).
4. Centralized & Remote Monitoring
Statistical surveillance of site metrics (enrollment, screen-failure, query rate/aging, AE rates, data trends/outliers, digit-preference, inlier/outlier detection); remote source-data review where permitted.
5. On-site Monitoring & SDV
Triggered by KRI signals or risk score. Targeted SDV focuses on consent, eligibility, primary-endpoint values, and SAEs (not 100% SDV). Verifies IMP accountability and essential/regulatory documents.
6. Visit Types & Frequency
Site qualification → Site Initiation Visit (SIV) → interim monitoring visits (risk-driven cadence) → Close-Out Visit (COV). Each generates a monitoring visit report filed to the TMF.
7. Escalation & Reporting
Significant/critical findings escalated to the sponsor and the Issue/CAPA log (QA-ISSUE); systemic issues to governance (PM-005). Monitoring oversight metrics reported to the study team periodically.