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생명과학 eQMS 20개 항목

Pharmacovigilance Adverse Event Reporting Checklist (ICH E2)

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Verifies that individual case safety reports are captured, assessed, and submitted within regulatory timelines for post-marketing pharmacovigilance. Use for case processing quality review and PV system audit.

ICH E2AICH E2D21 CFR 314.80GVP Module VI

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Case Intake and Validity

  • Does each case contain the four minimum criteria (identifiable reporter, patient, product, event)? *
  • Is the date of receipt (Day 0) recorded and used to start the reporting clock? *
  • Are all case sources (spontaneous, literature, studies, digital) captured under the PV system? *
  • Are duplicate cases identified and reconciled? *

Seriousness and Causality Assessment

  • Is seriousness assessed against the defined criteria (death, life-threatening, hospitalization, disability, congenital anomaly, medically important)? *
  • Is a causality assessment documented for the suspect product? *
  • Is expectedness assessed against the reference safety information (e.g., label/IB)? *
  • Record the case seriousness classification.

Coding and Data Quality

  • Are events coded using the current MedDRA version? *
  • Is the narrative complete, accurate, and consistent with the coded data? *
  • Is medical review performed by a qualified assessor? *
  • Are data privacy requirements observed in the case record? *

Expedited and Periodic Reporting

  • Are serious unexpected cases submitted within 15 calendar days? *
  • Are non-serious and other cases handled per the applicable timelines? *
  • Are reports submitted electronically (E2B) to the required authorities? *
  • Are aggregate reports (PSUR/PBRER) prepared on schedule? *

Follow-up and System Oversight

  • Is follow-up performed to obtain missing significant information? *
  • Are late or missed submissions investigated with CAPA? *
  • Is reconciliation performed between PV, complaints, and partner data exchange agreements? *
  • Is the Pharmacovigilance System Master File (PSMF) current where required?

Pharmacovigilance Adverse Event Reporting Checklist (ICH E2) 체크리스트 전체 다운로드

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