#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias

While structured data elements such as patient identifier,
medicine name and reaction, are fundamental for adverse event
reporting, they may not capture all relevant details. This is
where the narrative fields come in, allowing reporters to
disclose important contextual information, such as the patient’s
full clinical course. But how do PV assessors interact with these
narratives in spontaneous reports? What needs and challenges do
they experience? These and other questions were addressed in an
exploratory interview study by UMC researchers Joana Félix and
Alem Zekarias. 

Tune in to find out:


What challenges are PV assessors faced with, when working
with narratives? 

How could automation of certain tasks help streamline
narrative analyses in the future?

How can reporters craft narratives that effectively document
adverse events? 




Want to know more?


Pharmacovigilance assessors’ experiences interacting with
narrative fields in spontaneous reports: an exploratory interview
study – poster presented at the 23rd ISoP Annual Meeting “Global
Perspectives on Pharmacovigilance in the Digital Age and Advanced
Therapeutics”, 1–5 October 2024 Montreal, Canada.

Current Challenges in Pharmacovigilance: Pragmatic
Approaches, by The Council for International Organisations of
Medical Sciences (CIOMS). See page 133 on the role of narratives
in good case management practices. 






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