RECORDREFERENCE OUTLINE

Protocol Deviation Log

Deviation register recording date of occurrence and date of discovery separately so the duration of the condition is recoverable, classifying by impact on safety and data reliability rather than by inconvenience, escalating serious breaches on discovery, and carrying a pattern-analysis tab so corrective action is written against the systemic cause rather than the last occurrence. Maps to ICH E6(R3).

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH E6(R3)
DOCUMENT TYPE
Record
LAST UPDATED
August 2026
PURPOSE

Deviations are the normal friction between a written protocol and real participants. What distinguishes a well-run trial is not their absence but whether they are found quickly, classified honestly, and acted on when they cluster. The log fails when everything is classified minor, because uniform classification hides the few deviations that change data reliability or participant safety. The classification threshold is the sponsor’s determination.

What's Inside

✓Deviation register recording the date it occurred and the date it was discovered in separate fields
✓Site, participant and protocol section affected, so a systemic section problem becomes countable
✓Impact assessment on participant safety, data reliability and continued participation, each assessed separately
✓Classification against a written threshold rather than against the recorder’s personal sense of severity
✓Serious-breach escalation tracking with the date of discovery and the date of notification
✓Pattern analysis by category, count and sites affected, refreshed before corrective action is written
✓Study-report summary counts, reconciled to the register so the report matches the log

How to Use It

1Log at discovery rather than at resolution; otherwise the duration of the condition is unrecoverable, and duration determines exposure
2Record occurrence and discovery dates separately, because the gap between them is itself a monitoring finding
3Classify by impact against a written threshold; classifying by inconvenience produces a register where everything is minor
4Escalate a serious breach on discovery, not at the next scheduled review — the clock started when you knew
5Run the pattern analysis before writing corrective action, so the action addresses the cause rather than the last occurrence
6Reconcile the register to the study report counts, because a mismatch between them is found by whoever reviews both
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Deviation Register
2Impact Assessment
3Serious Breach Escalation
4Pattern Analysis
5Study Report Summary
REGULATORY CONTEXT

ICH E6(R3) sets the good clinical practice expectations for protocol compliance, for recording and reporting deviations, and for escalating serious breaches to the sponsor and the relevant parties. It does not write your classification thresholds, decide what counts as important for your protocol, or set your pattern-review cadence. Those are sponsor determinations. The register structure, the separated occurrence and discovery dates, and the pattern analysis are SPEQ practitioner synthesis, and this renders as a spreadsheet because a deviation log gets sorted and counted.

MAPPED STANDARDS
ICH E6(R3)
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