CFR (code of federal regulations)

Question 1

21 CFR 11

Answer 1

electronic records and electronic signatures

Question 2

21 CFR 11 SUBPART B

Answer 2

electronic records

Question 3

21 CFR 50

Answer 3

protection of human subjects

Question 4

21 CFR 50 SUBPART B

Answer 4

informed consent of human subjects
(protection of human subjects)

Question 5

21 CFR 50 SUBPART D

Answer 5

additional safeguards for CHILDREN
(protection of human subjects)

Question 6

21 CFR 56

Answer 6

institutional review boards

Question 7

21 CFR 56 SUBPART D

Answer 7

records and reports
(institutional review boards)

Question 8

21 CFR 56 SUBPART E

Answer 8

administrative actions for non-compliance
(institutional review boards)

Question 9

21 CFR 312

Answer 9

investigational new drug (IND)

Question 10

21 CFR 312 SUBPART B

Answer 10

IND application

Question 11

21 CFR 312 SUBPART C

Answer 11

administrative actions
(IND)

Question 12

21 CFR 312 SUBPART D

Answer 12

responsibilities of sponsors and investigators
(IND)

Question 13

21 CFR 312 SUBPART E

Answer 13

drugs intended to treat LIFE THREATENING and DEBILITATING illnesses
(IND)

Question 14

21 CFR 312 SUBPART G

Answer 14

drugs for investigational use in ANIMALS or IN-VITRO
(IND)

Question 15

21 CFR 812

Answer 15

Investigational device exemptions (IDE)

Question 16

21 CFR 812 SUBPART B

Answer 16

application and administrative actions
(IDE)

Question 17

21 CFR 812 SUBPART C

Answer 17

responsibilities of sponsors
(IDE)

Question 18

21 CFR 812 SUBPART D

Answer 18

IRB review and approval
(IDE)

Question 19

21 CFR 812 SUBPART E

Answer 19

responsibilities of investigators
(IDE)

Question 20

21 CFR 812 SUBPART G

Answer 20

records and reports
(IDE)

Question 21

45 CFR 46

Answer 21

protection of human subjects (PUBLIC WELFARE)

Question 22

43 CFR 46 SUBPART A

Answer 22

basic HHS policy for protection of human subjects
(public welfare)

Question 23

43 CFR 46 SUBPART B

Answer 23

additional protections for PREGNANT WOMEN, FETUSES, AND NEONATES
(public welfare)

Question 24

43 CFR 46 SUBPART C

Answer 24

protections pertaining to biomedical behavioural research involving PRISONERS
(public welfare)

Question 25

43 CFR 46 SUBPART D

Answer 25

protections for CHILDREN in research
(public welfare)

Question 26

43 CFR 46 SUBPART E

Answer 26

registration of IRB
(public welfare)