Important Flashcards
1
Q
CFR stands for:
A
Code of Federal Regulations
FDA regulations can be found in the CFR
2
Q
Title 21 (21CFR) houses regulations for:
A
Food and Drugs
3
Q
21CFR Part 11 covers which specific area…
A
Electronic Records
4
Q
21CFR Part 50 covers what area:
A
Protection of Human Subjects
Main concepts:
- Requirements for informed consent (21 CFR 50.25)
- Documentation of informed consent
- Exception from informed consent requirements for emergency use (21 CFR 50.24)
5
Q
21 CFR Part 56 covers:
A
Institutional Review Board
6
Q
21 CFR Part 312 covers:
A
Investigational New Drug Application (IND) Regulations
7
Q
21CFR Part 812 covers:
A
Investigational Device Exemptions (IDE)
8
Q
Title 45 of the CFR covers:
A
Public Welfare regulations
9
Q
45 CFR Part 46 covers:
A
Protection of Human Subjects
