← Template Library
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.
REGULATIONS MAPPED
EU GVP Module IX21 CFR 314.80
DOCUMENT TYPE
SOPLAST UPDATED
January 2025PURPOSE
A pharmacovigilance signal management procedure that defines how safety signals are detected, validated, assessed, prioritised, and actioned across the product lifecycle.
What's Inside
✓Signal detection methods and sources
✓Validation and prioritisation criteria
✓Assessment and benefit-risk evaluation
✓Recommendation and action tracking
✓Documentation and regulatory reporting
How to Use It
1Define detection sources and screening cadence
2Validate and prioritise emerging signals
3Assess confirmed signals for benefit-risk impact
4Decide and track resulting actions
5Document decisions and report as required
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, and 21 CFR 314.80 frames US postmarketing safety reporting. This procedure documents detection-to-action with a decision trail.