SOPREFERENCE OUTLINE

Signal Management Procedure

Pharmacovigilance signal management SOP covering detection, validation, prioritisation, benefit-risk assessment, and action tracking across the product lifecycle. Maps to EU GVP Module IX and 21 CFR 314.80.

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
EU GVP Module IX21 CFR 314.80
DOCUMENT TYPE
SOP
LAST UPDATED
January 2025
PURPOSE

A pharmacovigilance procedure defining how safety signals are detected, validated, prioritised, assessed, and actioned across a product's lifecycle, and how each decision is recorded. Signal management fails quietly: the record that matters in an inspection is not the signal that was escalated but the one that was dismissed, and this procedure exists to make the dismissal as traceable as the escalation.

What's Inside

✓Detection sources and methods — spontaneous reports, literature, clinical data, registries, and regulator communications
✓Screening cadence per data source, with the rationale for each frequency
✓Validation criteria distinguishing a validated signal from noise, applied consistently rather than case by case
✓Prioritisation criteria that bring serious or vulnerable-population signals forward regardless of case volume
✓Assessment and benefit-risk evaluation, including the evidence considered and the evidence sought and not found
✓Recommendations and action tracking through to label change, study commitment, or documented no-action
✓Documentation, regulatory reporting obligations, and the oversight and quality-control checks on the process

How to Use It

1Enumerate every data source and set a screening cadence for each, recording why that cadence is appropriate
2Apply the validation criteria as written — a signal dismissed against criteria invented for the occasion is not defensible
3Prioritise on seriousness and population rather than case count, and record the prioritisation decision
4Assess confirmed signals for benefit-risk impact, documenting the evidence you sought and could not obtain
5Track every recommendation to a closed action, including a documented decision to take none
6Review the process itself periodically, and record the oversight checks that confirm it ran as written
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 Definitions
2Roles and Responsibilities
3Signal Detection Sources and Methods
4Signal Validation and Prioritisation
5Signal Assessment and Benefit-Risk
6Recommendations and Action Tracking
7Documentation and Regulatory Reporting
8Quality Control and Oversight
REGULATORY CONTEXT

EU GVP Module IX defines the signal management lifecycle — detection, validation, confirmation, analysis, prioritisation, and recommendation for action — and expects the process to be described and auditable. In the United States, 21 CFR 314.80 frames postmarketing safety reporting obligations for approved products. Neither prescribes the screening cadence, the validation threshold, or the prioritisation rule for a given product; those are the marketing authorisation holder's determinations, and this procedure exists to state them in advance and record their application.

MAPPED STANDARDS
EU GVP Module IX21 CFR 314.80
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