Wed, Oct 19, 2022 11:00 AM EDT In this webinar, Advanced Clinical will explore best practices for writing custom patient narratives and how this approach adds value for sponsors, site staff, patients and regulators.
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. It makes it difficult for regulators to assess the cause of the safety issue and runs the risk that irrelevant data will get pulled into the adverse event determinant. However, when authors take the time to combine a patient’s relevant medical history with safety event details and focus on 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.
Director of Global Patient Safety
Times and Date:
Wed, Oct 19, 2022 11:00 AM EDT