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PLANREFERENCE OUTLINE
Clinical Monitoring Plan
Risk-based clinical monitoring plan identifying critical data and processes and setting the on-site/remote/centralised monitoring mix, visit scope, and escalation. Aligned to ICH E6(R3).
REGULATIONS MAPPED
ICH E6(R3)
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A clinical monitoring plan that defines the risk-based monitoring strategy for a trial — what is monitored, how often, and how critical data and processes are protected.
What's Inside
✓Risk-based monitoring strategy
✓Critical data and process identification
✓On-site, remote, and centralised monitoring mix
✓Monitoring visit scope and frequency
✓Escalation and issue-management workflow
How to Use It
1Identify the trial’s critical data and processes
2Set the monitoring mix proportionate to risk
3Define visit scope, frequency, and triggers
4Specify source data verification expectations
5Define escalation and follow-up handling
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
1Purpose, Scope, and Study Summary
2Risk Assessment and Critical-to-Quality Factors
3Monitoring Strategy and Methods
4Visit Types, Scope, and Frequency
5Source Data Verification Approach
6Issue Escalation and Management
7Reporting and Oversight
REGULATORY CONTEXT
ICH E6(R3) Good Clinical Practice expects a risk-based, quality-by-design approach to monitoring. This plan documents the strategy and the critical-to-quality focus E6(R3) requires.