Things I didn't Study, but Wish I Had Flashcards
Cards need to be finished, but are for questions I saw on the exam and struggled with.
1
Q
Who is responsible for determining risk/benefit and monitoring safety during a trial?
A
2
Q
What’s required for a “closed system?” (21 CFR 11)
A
3
Q
Can the FDA inspect IRB records?
A
4
Q
What sorts of things require an amendment to the IND?
A
5
Q
What requires an amendment to the investigator’s brochure?
A
6
Q
Study ICH guidelines thoroughly, especially for ICF requirements and initial IRB submission and continuing review.
A
7
Q
Review monitor responsibilities and monitoring plan, esp. for study closure.
A
8
Q
Review what is submitted with an IND application.
A
9
Q
Several Q’s about short form consent requirements/process.
A
10
Q
Q about commercial marketing for IDE.
A
11
Q
Qs about what Investigator agrees to when signing FDA 1572.
A
