On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
SUSAR
.
Show all posts
Showing posts with label
SUSAR
.
Show all posts
Monday, December 29, 2025
FDA guidance "Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies"
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Earlier this month, FDA issued its guidance " Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND an...
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Wednesday, June 21, 2023
SAE reporting - from non-serious AE to serious AE - one event or two events?
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An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious (therefore se...
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