Key points
- ICSR data must be entered completely, accurately, and consistently into the safety database.
- Case entry should reflect source documents faithfully, including patient, reporter, product, event, and timeline details.
- MedDRA coding, product coding, seriousness, expectedness, and other assessments must be applied correctly and consistently.
- Case narratives should be medically coherent, complete, and aligned with structured database fields.
- Quality control must verify source-to-database accuracy and identify discrepancies before submission.
- Inspection-ready evidence should demonstrate that QC findings are corrected and case quality is actively controlled.
What inspectors expect
Each point below should be supported by controlled documents and traceable records.
- ICSR data must be entered accurately and completely from source information.
- Coding and case assessments must be applied consistently and appropriately.
- Case narratives must support the clinical and regulatory interpretation of the report.
- Quality control must verify source-to-database accuracy before submission.
- Data discrepancies must be corrected and documented in a controlled manner.
Summary
Inspectors assess whether pharmacovigilance systems enter ICSR data accurately and perform effective quality control before reporting. They typically review source-to-database consistency, coding accuracy, narrative quality, QC checklists, and evidence that discrepancies are corrected in a controlled manner.
Common questions
These are the questions this page is designed to answer directly.
- How should ICSR data be entered in pharmacovigilance?
- What do inspectors check for case data entry and QC?
- How is quality control performed for ICSRs?
- What are common ICSR data entry errors?
- How do inspectors review MedDRA coding quality?
- What should be checked during pharmacovigilance QC review?
- How do you ensure ICSR database accuracy?
- What is ICSR quality control in pharmacovigilance?
- How do inspectors verify case narrative quality?
- What evidence is required for ICSR QC?
Evidence objects inspectors expect
Safety Database Case Record
- Structured entry of patient, reporter, product, and event information
- Correct capture of event dates, outcomes, seriousness criteria, and product exposure
- MedDRA coding of adverse events
- Drug dictionary coding of suspect and concomitant products
- Case narratives aligned with structured database fields
Case Processing QC Checklist
- Verification of minimum case information
- Checks against source documents for patient, reporter, product, and event details
- Review of MedDRA coding accuracy
- Review of seriousness and outcome fields
- Documentation of QC findings and corrections
Source Document Comparison Evidence
- Original source document linked to case record
- Traceability between verbatim report and coded database fields
- Verification that all reportable events were captured
- Consistency between source chronology and database dates
Narrative Quality Evidence
- Chronological and coherent case narrative
- Consistency between narrative and structured data
- Inclusion of relevant medical history and treatment course where available
- Absence of contradictions between fields and narrative
QC Discrepancy and Correction Evidence
- Documented discrepancies identified during QC
- Evidence of corrections made before case progression
- Escalation of significant data quality issues
- Final QC sign-off or workflow completion status
Regulatory Basis (Primary Sources)
- GVP Module VI – requirements for accurate collection, management, and reporting of ICSRs
- ICH E2A – clinical safety data management expectations for complete and consistent case data
- ICH E2D – post-approval safety data management and expedited reporting requirements
- MHRA GPvP guidance – expectations for ICSR quality and reporting compliance
- FDA postmarketing safety reporting guidance – requirements for accurate case information and reporting
Typical Inspection Questions (What Inspectors Ask)
- Show me the source document and how the case was entered into the database.
- How do you ensure MedDRA coding is accurate?
- What is checked during ICSR QC review?
- How do you document and correct QC discrepancies?
- How do you ensure the narrative matches the structured case data?
Failure patterns
Source information is entered inaccurately or incompletely into the safety database.
MedDRA coding does not reflect the reported event appropriately.
Structured fields and narrative contain inconsistencies or contradictions.
QC is performed superficially or not documented adequately.
Discrepancies identified during QC are not corrected or not traceable.
What good looks like
- Accurate and complete data entry reflecting the original source document.
- Consistent coding of events, products, and case assessments.
- Chronological, clear, and medically coherent case narratives.
- Documented QC checks demonstrating source-to-database verification.
- Prompt correction of discrepancies before case progression or submission.
Operationalisation
- Implement structured case data entry workflows within the safety database.
- Apply standardised coding rules for adverse events and medicinal products.
- Use QC checklists to verify source-to-database accuracy before submission.
- Ensure narratives are reviewed for completeness, chronology, and consistency.
- Document discrepancies identified during QC and confirm correction.
- Train case processors and QC reviewers on data integrity expectations.
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FAQ
What is checked during ICSR quality control?
ICSR QC typically checks source-to-database accuracy, completeness of required fields, coding accuracy, seriousness classification, outcome data, narrative quality, and consistency across the case record.
What is MedDRA coding in pharmacovigilance?
MedDRA coding is the process of converting reported adverse events into standardised medical terminology, allowing consistent safety reporting, analysis, and regulatory submission across global pharmacovigilance systems.
Why is MedDRA coding important in ICSR processing?
MedDRA coding standardises adverse event terminology and supports consistent safety analysis, reporting, and signal detection across cases.
How do inspectors review ICSR data entry quality?
Inspectors often compare original source documents against database records, focusing on whether the entered data, coding, and assessments accurately reflect the reported information.
What are common ICSR data entry errors?
Common errors include missing event details, incorrect dates, inaccurate seriousness criteria, inconsistent outcomes, poor coding choices, and narratives that do not match structured case fields.
What should a good ICSR narrative include?
A good narrative should present the case clearly and chronologically, including relevant patient context, product exposure, event development, treatment actions, and outcome, without contradicting structured database fields.
How are QC discrepancies handled in pharmacovigilance?
QC discrepancies should be documented, corrected in the safety database, and where necessary escalated or trended to strengthen case quality and process control.
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
International Council for Harmonisation (ICH)
- Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A)View source
- Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting (E2D)View source
U.S. Food and Drug Administration (FDA)
- Postmarketing Safety Reporting for Human Drug and Biological ProductsView source
UK MHRA (GOV.UK)
- Good Pharmacovigilance Practice (GPvP)View source