Events & reporting Flashcards
A response not anticipated in the investigator’s brochure
unexpected adverse drug event
What are these examples of: disability, hospitalization, incapacity, birth defect, congenital anomaly, and death
Serious adverse events
adverse event
symptom, sign, illness or experience that develops or worsens during the study. Can be related or unrelated to treatment
When should an unanticipated adverse device effect be reported?
within 10 days
Who should the PI alert of a serious adverse event?
The IRB and sponsor
How many days does the sponsor have to report a SAE to the FDA?
15 days
___ must report any potential serious risks associated with the investigational product to ___.
Sponsor & FDA
What is the time window when a IND safety report should be submitted to the FDA?
ASAP but within 15 calendar days
A _____ needs to be reported to the FDA within 15 days
unexpected adverse drug event
TRUE OR FALSE: an unexpected adverse drug event should be reported to the FDA
true
How soon should the FDA be alerted that an investigational product was discontinued due to unreasonable & significant risk to subjects?
Within 5 days
