CFR (code of federal regulations) Flashcards
21 CFR 11
electronic records and electronic signatures
21 CFR 11 SUBPART B
electronic records
21 CFR 50
protection of human subjects
21 CFR 50 SUBPART B
informed consent of human subjects
(protection of human subjects)
21 CFR 50 SUBPART D
additional safeguards for CHILDREN
(protection of human subjects)
21 CFR 56
institutional review boards
21 CFR 56 SUBPART D
records and reports
(institutional review boards)
21 CFR 56 SUBPART E
administrative actions for non-compliance
(institutional review boards)
21 CFR 312
investigational new drug (IND)
21 CFR 312 SUBPART B
IND application
21 CFR 312 SUBPART C
administrative actions
(IND)
21 CFR 312 SUBPART D
responsibilities of sponsors and investigators
(IND)
21 CFR 312 SUBPART E
drugs intended to treat LIFE THREATENING and DEBILITATING illnesses
(IND)
21 CFR 312 SUBPART G
drugs for investigational use in ANIMALS or IN-VITRO
(IND)
21 CFR 812
Investigational device exemptions (IDE)
21 CFR 812 SUBPART B
application and administrative actions
(IDE)
21 CFR 812 SUBPART C
responsibilities of sponsors
(IDE)
21 CFR 812 SUBPART D
IRB review and approval
(IDE)
21 CFR 812 SUBPART E
responsibilities of investigators
(IDE)
21 CFR 812 SUBPART G
records and reports
(IDE)
45 CFR 46
protection of human subjects (PUBLIC WELFARE)
43 CFR 46 SUBPART A
basic HHS policy for protection of human subjects
(public welfare)
43 CFR 46 SUBPART B
additional protections for PREGNANT WOMEN, FETUSES, AND NEONATES
(public welfare)
43 CFR 46 SUBPART C
protections pertaining to biomedical behavioural research involving PRISONERS
(public welfare)
