Title 21 Flashcards
Learn about electronic records and electronic signature
1
Q
What is the topic of Title 21?
A
Food and Drugs
2
Q
What is the topic of 21 CFR Part 11?
A
Electronic Records and Electronic Signatures
3
Q
Subpart A
A
General provisions
4
Q
Subpart B part 11
A
Electronic Records
5
Q
Subpart C part 11
A
Electronic Signatures
6
Q
What is the topic of 21 CFR part 50?
A
Protection of Human Subjects
6
Q
Subpart B part 50
A
Informed Consent of Human Subjects
6
Q
What is the Topic of 21 CFR Part 56
A
Institutional Review Board
7
Q
What is the Topic of 21 CFR Part 312
A
Investigational New Drug Application
8
Q
What is the topic of 21 CFR Part 812
A
Investigational Device Exemptions
