PLANREFERENCE OUTLINE

Risk-Based Quality Management (RBQM) Plan

A clinical Risk-Based Quality Management plan aligned to ICH E6(R3) and E8(R1): identifies the factors critical to quality, defines the risks to them, and sets the risk-based monitoring, key risk indicators, and quality tolerance limits that focus oversight on what matters to subject safety and data reliability.

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)ICH E8(R1)ICH E2A
DOCUMENT TYPE
Plan
LAST UPDATED
August 2026
PURPOSE

A Risk-Based Quality Management plan builds quality into a trial from design rather than inspecting it back in afterwards. It names the factors critical to subject safety and data reliability, assesses the risks to them, and sets the monitoring, indicators and tolerance limits that concentrate oversight there. The failure mode is a plan written once and never revisited, which then describes a trial that no longer exists.

What's Inside

✓Critical-to-quality factor register naming what must go right for subject safety and reliable results
✓Risk assessment per factor covering likelihood, impact and detectability, with the rationale recorded and not only the score
✓Risk control decisions — what is designed out, what is monitored, and what is knowingly accepted
✓Monitoring strategy allocating central, remote and on-site effort in proportion to the assessed risk
✓Key risk indicators with thresholds, and the named owner who acts when one of them moves
✓Quality tolerance limits with the predefined response to a breach, decided before any data accumulates
✓Risk review cadence, escalation routes, and the change control that keeps the plan current

How to Use It

1Identify the critical-to-quality factors before the trial opens, with the clinical, safety and data functions in the room together
2Assess each risk and record the reasoning, because a score with no rationale cannot be defended or revisited later
3Set monitoring effort in proportion to assessed risk rather than spreading it evenly across every site and variable
4Define each quality tolerance limit with the action a breach triggers, before any data exists to argue about
5Review the risks against accumulating data on the stated cadence — a plan frozen at start-up describes a different trial
6Put plan revisions under change control, so the version governing a given monitoring period stays reconstructable afterwards
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 and Scope
2Critical-to-Quality (CtQ) Factors
3Risk Assessment and Monitoring Strategy
4Key Risk Indicators and Quality Tolerance Limits
REGULATORY CONTEXT

ICH E6(R3) makes risk-based quality management the operating model for trial conduct, ICH E8(R1) expects the critical-to-quality factors to be identified during design rather than derived afterwards, and ICH E2A supplies the safety definitions the safety-related indicators here depend on. None of them tells you which factors are critical in your trial, where a tolerance limit sits, or how much monitoring is enough — those determinations are the sponsor’s. The register and indicator structure are SPEQ synthesis.

MAPPED STANDARDS
ICH E6(R3)ICH E8(R1)ICH E2A
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