Inspection triggers
- High ICSR volumes with unclear literature capture routes
- Inconsistent screening evidence across months
- Vendor use without documented oversight
What inspectors verify
- Defined, controlled search strategies and sources
- Documented screening and inclusion/exclusion decisions
- Evidence of periodic oversight and follow-up actions
- Traceability from literature hit → assessment → ICSR decision where applicable
Evidence map
Literature screening and review SOP
- Scope, sources, frequency, responsibilities
- Inclusion/exclusion criteria and escalation to case processing
Literature search log
- Search dates, databases, strings, results counts
- Screening outcomes and follow-up actions
Oversight meeting minutes
- Monthly governance agenda/minutes
- Actions, owners, and follow-up to closure
Common failure patterns
Search strategy not controlled or repeatable
Why it happens: Search strings/sources change ad hoc; evidence of cadence and execution is incomplete.
What inspectors do: Inspectors request historical proof of consistent searches and challenge traceability.
Screening decisions undocumented
Why it happens: Teams screen in email/notes with no controlled record.
What inspectors do: Absence of evidence is treated as non-compliance; findings focus on record integrity.
What good looks like
- Search strategy control (versioned strings/sources/cadence)
- Complete screening and disposition evidence
- Governance oversight with actions tracked to closure
Operationalisation
- Use a controlled search log and standardised screening workflow
- Hold a monthly oversight meeting with documented actions
- Periodically audit sample months for completeness and traceability
Mapped toolkits
These toolkits operationalise the evidence expectations above. Masters remain immutable; customers edit their own copies.
Literature Screening and Review Toolkit
Provides the SOP, controlled logs, and governance artefacts to operationalise compliant literature surveillance.