Best Practices for Ensuring Safety and Mitigating Risk in Clinical Research

Join our webinar!
Are Your Patient Narratives Too Broad? Best Practices for Ensuring Safety and Mitigating Risk in Clinical Research

Wednesday, 19 October 2022 11:00am EDT | 4:00pm BST | 5:00pm CEST 

Overview

Safety departments often take a one-size-fits-all approach to writing clinical narratives, and that could be introducing unnecessary risks to how individual cases—and later studies—are interpreted.

While it may seem prudent to include every single detail of a patient’s medical history in a case narrative, an overabundance of information buries the salient points. When authors take the time to combine a patient’s relevant medical history with safety event details and focus on the potential causes of the event, it is easy for regulators to understand what happened and what was the likely cause.

In this webinar, Advanced Clinical experts Claire Brazier, Director of Global Patient Safety, and Anna Fudim, Medical Director, will discuss how to write a custom patient narrative and why this approach adds value for sponsors, site staff, patients and regulators.

Key Learning Objectives:

• The most important rules for writing custom patient narratives
• The roles and responsibilities of investigators and case processors in narrative writing
• How to verify whether your narrative is correct, logical and fluent
• Best practices from real-world examples of custom patient narratives