As noted, there is not a requirement for providing narratives of discontinuations due to AEs. Whether one should provide narratives may depend on the overall clinical significance of the AEs. If "telling the story" helps interpret the safety profile for these events, it may be useful if for no other reason than to ease the work of the reviewer. However, I would probably limit the narratives to those events that were considered related to the product.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 09-Dec-2019 13:47
From: Anonymous Member
Subject: Clinical Study Report Narratives
This message was posted by a user wishing to remain anonymous
Dear Forum-
In the E3 Guidance document, Content and Structure of Clinical Study Reports, it is clear that narratives are needed for deaths and other SAEs; however, it is unclear about other significant adverse events. Should CSRs contain narratives for any Discontinuation Due to AEs?
Any guidance is greatly appreciated.
Thank you!