What are the five types of SAEs? ✔️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? ✔️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? ✔️UADE

Unanticipated adverse device event

What are the UADE reporting timelines for investigators and sponsors?

✔️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? ✔️45 CFR 46 subpart B

What part of the code of regulations discusses children? ✔️45 CFR 46

subpart D

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jordancarter 7 months ago

This study guide is clear, well-organized, and covers all the essential topics. The explanations are concise, making complex concepts easier to understand. It could benefit from more practice questions, but overall, it's a great resource for efficient studying. Highly recommend!

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