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).

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
Plan
LAST UPDATED
January 2025
PURPOSE

The plan that fixes a trial's monitoring strategy before the first site is activated — which data and processes are critical to participant safety and result reliability, how each will be monitored, and what happens when something is found. E6(R3) asks for monitoring proportionate to risk, which means the plan has to name the risks it is proportionate to.

What's Inside

✓Study summary and the risk assessment behind the strategy, including the critical-to-quality factors identified
✓Critical data and processes, named specifically rather than as categories
✓The monitoring mix — on-site, remote, and centralised — with the rationale for the balance chosen
✓Visit types, scope, frequency, and the triggers that change any of them mid-trial
✓Source data verification approach, including what is verified in full, what is sampled, and why
✓Issue escalation and management workflow, with thresholds and named decision owners
✓Reporting, oversight, and the review cadence at which the strategy itself is reconsidered

How to Use It

1Identify the critical-to-quality factors first; the monitoring strategy is derived from them, not the other way round
2Name critical data and processes specifically, so a monitor can tell what is in scope without interpretation
3Set the monitoring mix proportionate to the identified risks, and record why centralised monitoring does or does not displace on-site visits
4Define the SDV approach explicitly — full, targeted, or sampled — and state the basis for the sampling
5Fix escalation thresholds and decision owners in advance, so a finding does not wait on an ad hoc judgement
6Review the strategy at the stated cadence and adapt it to what the accumulating data shows, recording each change
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) expects a quality-by-design, risk-proportionate approach in which critical-to-quality factors are identified and monitoring is designed around them, replacing the assumption that complete source data verification is the default. It prescribes no monitoring mix, no visit frequency, and no SDV percentage; those are the sponsor's determinations, made against the trial's own risks and recorded in this plan. The structure here is SPEQ synthesis of E6(R3) expectations and is not a sponsor-specific recommendation.

MAPPED STANDARDS
ICH E6(R3)
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