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eQMS para ciencias de la vida 20 elementos

Pharmacovigilance Adverse Event Reporting Checklist (ICH E2)

Esta lista de verificación está en inglés.

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?

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