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What are the five types of SAEs? ✔ï¸1) life threatening2)
results in death
3) hospitalization
4) results in disability
5) birth defect
What are the SAE reporting timelines for investors and sponsors in drug
trials? ✔ï¸Investigators to sponsor= 24 hrs
- whether or not it's drug related
- must include an assessment of causality
Sponsor to FDA and all other investigators =15 calendar days
-qualifies for reporting:
1) unexpected and serious
2) SAEs from other studies using same drug
3) findings from animal testing
4) increased rate of occurrence
What is an SAE for device trials? ✔ï¸UADE
Unanticipated adverse device event
What are the UADE reporting timelines for investigators and sponsors?
✔ï¸Investigator to sponsor AND IRB= 10 working days
Sponsor to FDA and all reviewing IRBs = 10 working days
What does part of the code of regulations discusses participation of
pregnant women in clinical trials? ✔ï¸45 CFR 46 subpart B
What part of the code of regulations discusses children? ✔ï¸45 CFR 46
subpart D
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