Key points
- Literature search results must be systematically screened to identify potential individual case safety reports (ICSRs) associated with medicinal products.
- Screening decisions must be documented with clear rationale for inclusion, exclusion, and duplicate classification.
- Screening outcomes must be traceable from literature hit to safety assessment and ICSR processing where applicable.
- Ambiguous publications should follow defined escalation pathways to ensure consistent case identification decisions.
- Organisations should demonstrate controlled screening procedures supported by training, SOPs, and quality control mechanisms.
- Screening processes should ensure that reportable safety information is consistently identified and processed within regulatory reporting timelines.
What inspectors expect
Each point below should be supported by controlled documents and traceable records.
- Literature screening decisions must follow defined and documented procedures.
- Inclusion and exclusion decisions must be recorded with sufficient rationale.
- Potential ICSRs must be escalated promptly for case processing.
- Screening records must demonstrate traceability from literature hit to case processing or exclusion decision.
- Screening processes must demonstrate consistency through training and quality control mechanisms.
Summary
Inspectors assess whether literature search results are screened consistently, decisions are documented with clear rationale, and potential safety cases are reliably identified and escalated. They typically examine screening records, SOPs, decision criteria, and traceability between literature hits and case processing.
Common questions
These are the questions this page is designed to answer directly.
- How should literature search results be screened in pharmacovigilance?
- What do inspectors expect for literature screening decisions?
- How do you identify reportable ICSRs in scientific literature?
- What documentation is required for literature screening decisions?
- What evidence do inspectors request for literature screening?
- How should title and abstract screening be performed for PV literature?
- What should be recorded when excluding literature search results?
- How are ambiguous publications handled during literature screening?
- What inspection findings occur for literature screening processes?
- How should literature screening decisions be documented for inspection?
- How do inspectors test traceability from literature screening to ICSR processing?
- What controls should exist for literature screening consistency?
Evidence objects inspectors expect
Literature Screening SOP
- Defined screening workflow from literature hit to decision outcome
- Title and abstract screening methodology
- Full-text review triggers and escalation criteria
- Defined inclusion and exclusion decision rules
- Responsibilities for screening and quality control
- Escalation pathway for potential safety cases
Literature Screening Decision Log
- Unique identifier for each literature record
- Title and abstract screening outcome
- Full-text review decision where applicable
- Documented inclusion or exclusion rationale
- Duplicate classification where relevant
- Reviewer identity and date of screening
ICSR Identification Documentation
- Documentation of suspected adverse reaction information identified in literature
- Evidence linking literature publication to case processing decision
- Traceability from screening outcome to safety database entry
- Assessment notes supporting case validity determination
Screening Criteria and Decision Framework
- Defined criteria for identifying potential ICSRs
- Examples of reportable versus non-reportable literature cases
- Guidance for handling ambiguous publications
- Defined rules for duplicate case handling
Screening Quality Control Evidence
- QC sampling of screening decisions
- Dual-review processes where implemented
- Review of screening accuracy or consistency
- Documentation of corrections or follow-up actions
Regulatory Basis (Primary Sources)
- GVP Module VI – literature reports must be evaluated for ICSR reporting
- ICH E2D – literature cases are valid sources of adverse reaction reporting
- EMA Medical Literature Monitoring guidance – screening expectations for literature monitoring
- MHRA pharmacovigilance guidance – responsibility for monitoring relevant literature
Typical Inspection Questions (What Inspectors Ask)
- How are literature search results screened for potential ICSRs?
- What criteria determine whether a publication contains a reportable case?
- How are screening decisions documented and reviewed?
- Show me evidence of screening decisions for recent literature searches.
- How do you ensure screening decisions are consistent across reviewers?
- Trace a literature publication from screening through to case processing.
Failure patterns
Screening decisions are not documented: Inspectors often find that literature search results are reviewed informally without documented rationale for inclusion or exclusion.
Inconsistent case identification: Different reviewers apply screening criteria differently, leading to inconsistent identification of potential ICSRs.
Ambiguous publications not escalated: Publications containing possible safety signals are excluded prematurely without documented assessment.
Traceability gaps: Organisations cannot demonstrate how a literature hit was assessed and whether it was escalated to case processing.
Lack of defined screening criteria: Inspectors observe screening performed based on reviewer judgement rather than defined decision rules.
What good looks like
- Screening decisions are recorded with clear rationale and reviewer attribution.
- Potential ICSRs are escalated promptly and traceably to case processing workflows.
- Screening criteria are clearly defined and applied consistently across reviewers.
- Traceability from literature hit to safety case processing is retrieval-ready.
- Quality control checks confirm consistency of screening decisions.
Operationalisation
- Define screening criteria for identifying potential ICSRs within the Literature Surveillance SOP.
- Implement structured screening logs capturing decision rationale and reviewer attribution.
- Ensure ambiguous publications are escalated for further safety assessment rather than excluded prematurely.
- Link screening records to case processing workflows to ensure traceability.
- Introduce quality control checks to confirm consistency of screening decisions.
- Provide training for reviewers performing literature screening activities.
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FAQ
How are literature search results screened for pharmacovigilance?
Literature search results are typically screened first at title and abstract level. Publications suggesting a potential adverse reaction are then reviewed in full text to determine whether a reportable ICSR exists.
What qualifies as a literature case for pharmacovigilance?
A literature case generally contains the minimum information required for an individual case safety report: an identifiable patient, identifiable reporter, suspect medicinal product, and suspected adverse reaction.
Must screening decisions be documented?
Yes. Inspectors expect evidence that literature search results have been reviewed systematically and that inclusion or exclusion decisions are documented with clear rationale.
How should ambiguous publications be handled?
Ambiguous publications should be escalated for further safety review rather than excluded prematurely. The rationale for final decisions should be documented.
Do inspectors test literature screening processes?
Yes. Inspectors frequently request screening logs and select publications to trace from literature search results through to case processing or documented exclusion.
Sources
Primary guidance used to inform this map. This page is a structured interpretation layer; always validate against the original source documents.
European Medicines Agency (EMA)
- Guideline on good pharmacovigilance practices (GVP) – Module VIView source
- Medical literature monitoringView source
International Council for Harmonisation (ICH)
- Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)View source