Protocol Deviation Log — GLPI103-301
| Field | Value |
|---|---|
| Document ID | QA-DEV |
| Version | 1.0 |
| Standard | ICH E6(R3); E3 (CSR §10.2) |
| Confidentiality | Confidential |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Quality Assurance | Initial log |
Categorization
- Major (important): may affect subject rights/safety or primary data integrity → may exclude subject from PPS.
- Minor: administrative/process; no impact on key data.
Deviation Log (summary)
| Category | Description (illustrative) | Impact (PPS) | n |
|---|---|---|---|
| Major | Eligibility criterion not met / confirmed post-randomization | Excluded from PPS | — |
| Major | Prohibited concomitant medication | Excluded from PPS | — |
| Major | Significant non-compliance (<80% adherence) | Excluded from PPS | — |
| Minor | Visit-window deviation (>±7 days) | No PPS impact | (per DQE query log) |
| Total major (this dataset) | PPS exclusions | 53 |
Data Note (this study)
The simulated dataset models 53 major protocol deviations (8.0% of randomized); consequently the Per-Protocol Set (847) is a strict subset of the Full Analysis Set (900) — i.e., PPS ≠ FAS (SAP-301 §6; CSR-301 §10.2; ADRG §7). The primary efficacy conclusions are consistent between FAS and PPS, supporting robustness to deviation-related exclusions. In a real study, individual deviations would be itemized here and reconciled before database lock.