Clinical Trials Flashcards
0
Q
21 CFR 54
A
Financial Disclosure by Clinical Investigator
1
Q
21 CFR 50
A
Protection of Human Subjects
2
Q
21 CFR 56
A
Institutional Review Board
3
Q
21 CFR 312
A
Investigational New Drug Application
4
Q
21 CFR 812
A
Investigational Device Exemption
5
Q
21 CFR 46
A
Protection of Human Subjects
6
Q
21 CFR 201
A
Labeling
7
Q
21 CFR 320
A
Bioavailability and Bioequivalence Requirements
8
Q
21 CFR 312.23
A
Investigational New Drug (IND) Application Process
9
Q
21 CFR 812.20, .25, .27
A
Investigational Device Exemption Application Process
10
Q
21 CFR 312.23(a)(1)
A
Form FDA 1571 (IND)
11
Q
21 CFR 312.53(c)
A
Form FDA 1572 (Statement of Investigator)
12
Q
21 CR 812.43(c)
A
Form FDA 1572 not required by devices
13
Q
21 CFR 312.120
A
Foreign Clinical Trials not conducted under an IND
14
Q
21 CFR 312.52
A
Legal Representation (Transfer of Obligations)
