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What Do Inspectors Check for ICSR Case Intake and Source Management?

Pharmacovigilance systems must ensure all safety information is captured, validated, and documented at intake. Regulators expect clear processes for identifying sources, confirming minimum case criteria, determining day zero, and ensuring traceability of all incoming safety information.

For: Founders, CEOs & MDs·PV Leads·QA/Compliance·Scientists tasked with documentation

Alignment: Global pharmacovigilance principles (ICH-aligned) and inspection practices

Most useful when: Preparing for inspection, setting up a process, or closing a documentation gap

Key points

  • All safety information must be captured through defined intake processes.
  • Minimum case criteria must be confirmed before a case is processed.
  • Day zero must be determined consistently based on when valid information is received.
  • All sources of safety information must be identified and documented.
  • Case intake processes must ensure traceability from source through intake documentation to safety database entry.
  • Inspection-ready evidence should demonstrate complete and controlled case intake procedures.

What inspectors expect

Each point below should be supported by controlled documents and traceable records.

  • All safety information must be captured through controlled processes.
  • Minimum case criteria must be verified before case creation.
  • Day zero must be consistently determined.
  • Case sources must be clearly documented.
  • Traceability from source through intake documentation to database entry must be maintained.

Summary

Inspectors assess whether pharmacovigilance systems capture, validate, and document safety information at intake. They typically review how cases are received, how minimum criteria are confirmed, how day zero is determined, and how source information is traceable from original receipt through to database entry.

Common questions

These are the questions this page is designed to answer directly.

  • What is ICSR case intake in pharmacovigilance?
  • How is day zero determined for ICSRs?
  • What are the minimum case criteria?
  • What sources generate ICSRs?
  • How do inspectors check case intake processes?
  • What documentation is required at case intake?
  • How are safety reports captured in PV systems?
  • What triggers case creation in pharmacovigilance?
  • What is the role of intake forms in PV?
  • How do inspectors verify case receipt and intake?

Evidence objects inspectors expect

ICSR Intake Form

  • Structured capture of patient, reporter, product, and event information
  • Documentation of source (e.g. HCP, patient, literature, partner)
  • Initial seriousness and causality indicators
  • Date of receipt and validation of minimum criteria

Case Source Documentation

  • Original source documents such as emails, call logs, or literature articles
  • Identification of source type (spontaneous, literature, clinical trial, partner)
  • Documentation linking source to intake record
  • Traceability between source document and safety database entry

Minimum Case Criteria Assessment

  • Evidence of identifiable patient
  • Evidence of identifiable reporter
  • Suspect medicinal product
  • Adverse event description
  • Documentation confirming case validity

Day Zero Determination Records

  • Date of first awareness of a valid case
  • Documentation supporting day zero decision
  • Consistency between intake record and database entry
  • Traceability to reporting timelines

Intake Process SOP

  • Defined intake workflow
  • Roles and responsibilities for case receipt
  • Instructions for validating minimum case criteria
  • Procedures for documenting case sources

Regulatory Basis (Primary Sources)

  • GVP Module VI – requirements for collection and management of ICSRs
  • ICH E2D – post-approval safety data management
  • ICH E2A – minimum case criteria requirements
  • MHRA GPvP guidance – safety reporting obligations
  • FDA 21 CFR 314.80 – postmarketing reporting requirements

Typical Inspection Questions (What Inspectors Ask)

  • How do you capture incoming safety information?
  • How do you determine whether a case is valid?
  • How do you define and document day zero?
  • Show me the original source and how it appears in your database.
  • What sources generate ICSRs in your system?

Failure patterns

Cases are created without confirming minimum case criteria.

Day zero is incorrectly determined or inconsistently applied.

Source information is incomplete or not documented.

Lack of traceability between source documents, intake forms, and database records.

Intake processes are informal or not defined in SOPs.

What good looks like

  • Structured intake forms capturing all required information.
  • Consistent validation of minimum case criteria.
  • Clear and documented determination of day zero.
  • Full traceability from source document to intake record to database entry.
  • Defined intake processes followed consistently.

Operationalisation

  • Implement structured intake forms for all safety information.
  • Define minimum case criteria and validation steps.
  • Ensure all sources of safety information are documented.
  • Standardise day zero determination rules.
  • Ensure traceability from source through intake documentation to safety database.
  • Train staff on intake procedures and requirements.

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FAQ

What is day zero in pharmacovigilance?

Day zero is the date when a company first becomes aware of a valid ICSR containing the minimum required information.

What are the four minimum criteria for an ICSR?

The four minimum criteria are an identifiable patient, identifiable reporter, suspect medicinal product, and an adverse event. A case becomes valid for reporting once all four elements are present.

What sources generate ICSRs?

Sources include spontaneous reports, literature, clinical trials, patient support programmes, and partner organisations.

Do inspectors review intake processes?

Yes. Inspectors frequently review intake forms, source documentation, and day zero determination.

Why is case intake important?

Case intake ensures that all safety information is captured, validated, and processed correctly within regulatory timelines.

What are common intake failures?

Common failures include missing minimum criteria, incorrect day zero, incomplete source documentation, and lack of traceability.

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 VI
    View source

FDA

ICH

MHRA