Protocol Deviation Log — GLPI103-301
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The protocol deviation log — the record of departures from the protocol and their significance.
Why it exists. No trial runs perfectly; what matters is that deviations are captured, classified (important vs minor), and assessed for impact. The log feeds the CSR's deviation reporting (E3 §10.2).
How it is produced here. It is a quality record: a plan or log that shows how the program controls quality and builds the audit trail sitting behind every other document.
Format & governing standard. ICH E6(R3); E3 (CSR §10.2)
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
No trial runs perfectly; what matters is that departures from the protocol are captured and sorted into 'important' versus minor, then assessed for whether they could affect the results. Being able to show this log is itself a sign of a well-run trial.
- 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.
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