Guidelines for Pharmacovigilance Case Narratives Review

1) Purpose

The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives to ensure accuracy, completeness, and compliance with regulatory requirements.

2) Scope

This SOP applies to personnel responsible for reviewing pharmacovigilance case narratives, including pharmacovigilance scientists, medical reviewers, and quality assurance professionals.

3) Responsibilities

The Pharmacovigilance Case Reviewer is responsible for conducting thorough assessments of case narratives. Medical reviewers provide clinical expertise and oversight during review processes.

4) Procedure

4.1 Case Narrative Submission

1. Receive pharmacovigilance case narratives from data entry personnel or case processors for review.
2. Verify completeness of narrative content, including patient demographics, medical history, adverse event details, and clinical outcomes.

4.2 Narrative Review Criteria

1. Evaluate case narratives for accuracy, clarity, and adherence to pharmacovigilance guidelines and reporting requirements.
2. Assess consistency between narrative content and source documents, including adverse event reports, medical records, and investigator notes.

4.3 Medical Review and Assessment

1. Engage medical reviewers to provide clinical evaluation and interpretation of case narrative information, including causality assessment and clinical significance of adverse events.
2. Collaborate with medical reviewers to resolve discrepancies, clarify medical terminology, and ensure comprehensive understanding of case details.

4.4 Quality Assurance Checks

1. Conduct quality assurance checks to verify completeness of narrative data, accuracy of data coding, and compliance with standard operating procedures.
2. Document findings, observations, and recommendations for corrective actions or further investigation as necessary.

4.5 Narrative Approval and Documentation

1. Approve reviewed case narratives based on assessment outcomes and regulatory compliance.
2. Prepare and maintain documentation of narrative review activities, including reviewer comments, revisions, and approval status.

4.6 Compliance Reporting

1. Report any identified non-compliance issues, discrepancies, or adverse findings related to case narratives to pharmacovigilance management and regulatory authorities as required.
2. Implement corrective actions and preventive measures to address compliance gaps and improve narrative review processes.

4.7 Continuous Improvement

1. Conduct periodic reviews and audits of narrative review procedures to identify opportunities for process improvement, efficiency enhancements, and training needs.
2. Implement enhancements based on lessons learned, best practices, and regulatory updates to optimize narrative review and quality assurance practices.

5) Abbreviations, if any

PV – Pharmacovigilance, SOP – Standard Operating Procedure

6) Documents, if any

Case narrative review checklist, reviewer comments log, quality assurance reports.

7) Reference, if any

EMA Guideline on Good Pharmacovigilance Practices (GVP) Module VI – Management and Reporting of Adverse Reactions to Medicinal Products, FDA Guidance for Industry – Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products.

8) SOP Version

Version 1.0