Guidelines for Writing Pharmacovigilance Case Narratives

1) Purpose

The purpose of this SOP is to establish standardized procedures for writing case narratives in pharmacovigilance to ensure clear, concise, and accurate documentation of adverse event reports.

2) Scope

This SOP applies to all pharmacovigilance personnel involved in writing case narratives, including safety specialists, medical writers, and managers.

3) Responsibilities

The Case Narrative Writing Team is responsible for drafting and finalizing case narratives. The Pharmacovigilance (PV) Manager oversees the process to ensure compliance with regulatory requirements and internal standards.

4) Procedure

4.1 Case Narrative Preparation

1. Receive the case report and relevant data from the Case Assessment Team.
2. Review the case details, including patient information, adverse event description, and medical history.
3. Ensure all necessary information is available to draft a comprehensive case narrative.

4.2 Drafting the Case Narrative

1. Begin with a clear and concise introduction that summarizes the case, including patient demographics and key event details.
2. Describe the adverse event in chronological order, detailing the onset, duration, and resolution of symptoms.
3. Include relevant medical history, concomitant medications, and any other pertinent clinical information.
4. Document the results of any tests or investigations related to the adverse event.
5. Provide an assessment of the seriousness, expectedness, and causality of the adverse event.

4.3 Review and Quality Control

1. Conduct a peer review of the draft narrative to ensure accuracy, clarity, and completeness.
2. Address any feedback or revisions suggested during the peer review process.
3. Perform a final quality control check to ensure the narrative meets all regulatory and internal standards.

4.4 Finalizing the Case Narrative

1. Incorporate any final edits and ensure the narrative is free of errors.
2. Submit the finalized case narrative to the pharmacovigilance database and attach it to the corresponding case file.
3. Ensure the narrative is appropriately formatted and compliant with regulatory submission requirements.

4.5 Documentation and Record Keeping

1. Maintain detailed records of all case narratives, including drafts, peer reviews, and final versions.
2. Ensure all documentation is securely stored and easily accessible for audits and inspections.
3. Keep a log of all data corrections and updates made during the case narrative writing process.

4.6 Training and Communication

1. Communicate case narrative writing procedures and updates to all relevant staff members.
2. Provide training on narrative writing tools and techniques to ensure consistency and quality.
3. Report any issues or challenges encountered during narrative writing to the PV Manager.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Case reports, narrative drafts, peer review comments, final narratives, quality control reports.

7) Reference, if any

ICH E2E Pharmacovigilance Planning, EU Good Pharmacovigilance Practices (GVP) Module VI.

8) SOP Version

Version 1.0