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What is the definition of a clinical adverse event?
(AD-vers eh-VENT) An undesired effect of a drug or other type of treatment, such as surgery. Adverse events can range from mild to severe and can be life-threatening.
What is a SAE in clinical trials?
SAE is short for Serious Adverse Event. An SAE is any untoward medical occurrence in a patient or research participant, which does not have a causal relationship with the treatment, and: is fatal, and/or. is life-threatening for the particpant, and/or.
What are the 4 criteria for adverse event reporting?
.fda.gov/Safety/MedWatch or call 1-800-FDA-1088.
What is reasonable possibility in clinical trials?
Reasonable possibility means there is evidence to suggest a causal relationship between the drug and the adverse event.
How to report adverse events in clinical trials?
SAE should be reported to the sponsor within 24 hours of the investigator site team knowledge of the event whether verbally or in writing. A full report is to follow with the details and outcome of the event. It should also be recorded and documented as the case with AE.
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Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.
What are the FDA guidelines for reporting adverse events?
An investigator (if he/she is not a sponsor-investigator) must report to the sponsor any serious adverse event within 24 hours of investigator learning about the event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there
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