SOPREFERENCE OUTLINE

Safety Literature Monitoring Procedure

Literature-monitoring procedure and per-cycle search record, scoped by active substance rather than brand, with search strings captured verbatim so a reviewer can re-run them. Covers frequency and its justification, explicit screening criteria, the cycle log, and the cases arising. Maps to ICH E2D(R1) and EU GVP Module VI.

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 E2D(R1)EU GVP Modules
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

Systematic literature review is a recognised source of post-approval safety information, and awareness of a case in the literature starts the same reporting clock as a spontaneous report. The work is not reading papers — it is designing a search that can be repeated and defended months later. The recurring finding is an unreproducible search rather than a missed case.

What's Inside

✓Scope stated by active substance, with the products and obligated territories each substance carries
✓Databases named, with search strings captured verbatim including fields, limits and truncation
✓Frequency per substance with the basis recorded, since the interval is itself a compliance decision
✓Explicit inclusion and exclusion screening criteria, applied before anyone reads for interest
✓Per-cycle record of period, hits, screened, qualifying cases and who performed the search
✓Cases arising, each carrying its day zero and the route it took into the safety database
✓Retained result sets and the reason recorded for each exclusion, not only for each inclusion

How to Use It

1Scope by active substance rather than brand; a brand-name search misses publications naming only the substance, which is most of the literature.
2Record search strings exactly as entered, including operators and truncation; a paraphrased string is not a reproducible search.
3Justify the frequency for each substance, because the interval between searches decides how late an awareness date can be.
4Apply the screening criteria as written and record the reason for each exclusion; unexplained exclusions read as selection.
5Retain the result set for every cycle — evidence that the cycle ran is as much a part of compliance as the cases it found.
6Anchor day zero for a qualifying case to a defined point in the cycle and apply that convention consistently, not case by case.
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
1Scope of Monitoring
2Databases and Search Strategy
3Frequency and Schedule
4Screening Criteria
5Cycle Record
6Cases Arising and Approval
REGULATORY CONTEXT

ICH E2D(R1) establishes literature as a source of post-approval safety information and the awareness concept from which the reporting clock runs; EU GVP Module VI sets the literature-monitoring expectations for EU-authorised products. Neither picks your databases, writes your search strings, or fixes the interval between cycles — the search design, its frequency and the screening criteria are your organisation’s decisions, and they are what a reviewer re-performs. The procedure structure is SPEQ’s practitioner synthesis.

MAPPED STANDARDS
ICH E2D(R1)EU GVP Modules
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