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