Patient Safety Narratives in Clinical Studies
Clear, compliant, and insightful patient safety narratives for regulatory submissions, inspections, and internal safety reviews. Our expert medical writers provide end-to-end support for both large and small projects, ensuring a modern, scalable, and quality-focused approach.
What Are Patient Safety Narratives?
Patient safety narratives are concise, chronological accounts of significant adverse events in clinical studies, required for regulatory compliance and transparent reporting.
Why They Matter
Narratives are essential for regulatory submissions, providing a clear account of each serious or significant adverse event. They support safety evaluation and ensure compliance with ICH E3 and global guidelines.
- Required for deaths, serious adverse events, and events of special interest
- Prepared for all study phases and populations
- Enable transparent, consistent safety reporting
Key Regulatory Guidance
ICH E3 (Section 12.3.2) and EMA guidelines specify the structure, content, and placement of narratives in Clinical Study Reports (CSRs).
- Include all relevant clinical details and outcomes
- Omit or briefly describe events clearly unrelated to the study drug
- Place narratives in the main text or as an appendix, depending on number and complexity
What Should a Patient Safety Narrative Include?
A well-prepared narrative covers all clinically relevant aspects of the event, patient, and study context.
Event Details
Nature, intensity, outcome, and clinical course of the event, including timing and relevant lab measures.
Patient & Study Info
Patient identifier, age, sex, clinical condition, disease, relevant history, and study drug details.
Actions & Outcomes
Action taken with study drug, interventions, post-mortem findings (if any), and causality assessment.
Our Narrative Development Process
A proven, quality-focused workflow for efficient and consistent narrative production.
Template & Data Review
Develop a flexible template and review all available data sources (CRFs, CIOMS, MedWatch, listings) for accuracy and completeness.
Drafting & Review
Prepare first drafts, conduct peer and clinical review, and revise based on feedback for scientific and editorial accuracy.
QC, Approval & Delivery
Rigorous quality control, sponsor approval, and batch delivery for efficient project management and consistency.
Ensuring Consistency & Efficient Delivery
Best practices for managing large-scale narrative projects.
Project Management
Assign a single point of contact, use shared tracking tools, and maintain clear communication for large projects.
Consistency & Updates
Peer review and regular updates ensure consistency across all narratives, even as project scope evolves.
Batch Delivery
Deliver narratives in manageable batches for timely review and feedback, optimizing efficiency and quality.
Future Directions: Automation & Innovation
Embracing technology to streamline narrative preparation and ensure regulatory compliance.
Automation in Narrative Writing
Automated tools and programming (e.g., from SAS datasets) can accelerate narrative preparation, improve standardization, and reduce costs. Medical Writer review remains essential for clinical accuracy and regulatory compliance.
Evolving Regulatory Landscape
As regulatory expectations evolve, our processes and technology adapt to ensure ongoing compliance and best-in-class reporting for our clients.