PPR-043 - Qualitative assessment of challenges in reporting adverse events in clinical trials: A site management office perspective

• At: Copenhagen (Denmark) (2025)
• Type: Poster
• Poster code: PPR-043
• By: BHANDARI, Ramesh (KLE College Of Pharmacy Belagavi, KLE Academy of Higher Education and Research, India)
• Co-author(s): Dr Ramesh Bhandari (KLE College Of Pharmacy Belagavi, KLE Academy of Higher Education and Research, Belagavi, India)
  Ms. Janhavi Prabhu (KLE College Of Pharmacy Belagavi, KLE Academy of Higher Education and Research, Belagavi, India)
  Dr. Madiwalayya Ganachari (KLE College Of Pharmacy Belagavi, KLE Academy of Higher Education and Research, Belagavi, India)
  
• Abstract:

  Introduction: Evaluating harm in a clinical study is more challenging than assessing benefits. Literature suggests that adverse events are often underreported. The aim of the study was to identify the challenges to the collection, reporting, and analysis of adverse events (AEs) in clinical trials.
  
  Method: A single-center, face-to-face interview..

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