regulations, forms, definitions

Question 1

21 CFR 11

Answer 1

electronic signatures, electronic records

Question 2

21 CFR 50

Answer 2

informed consent of human subjects

Question 3

21 CFR 50.25

Answer 3

elements of informed consent

Question 4

21 CFR 50.20

Answer 4

general requirements for informed consent

Question 5

21 CFR 50.23

Answer 5

exception from general requirements of informed consent

Question 6

21 CFR 50.24

Answer 6

exception from informed consent requirements for emergency research

Question 7

21 CFR 50.27

Answer 7

documentation of informed consent

Question 8

21 CFR 50 subpart D

Answer 8

additional safeguards for children in clinical investigations

Question 9

21 CFR 50.51

Answer 9

clinical investigations NOT involving greater than minimal risk for children

Question 10

21 CFR 50.52

Answer 10

clinical investigations INVOLVING greater than minimal risk but presenting prospect of direct benefit to subjects - children

Question 11

21 CFR 50.53

Answer 11

clinical investigations INVOLVING greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the disorder or condition - children

Question 12

21 CFR 50.54

Answer 12

clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting health/welfare of children

Question 13

21 CFR 50.55

Answer 13

requirements for permission by parents or guardians and for assent by children

Question 14

21 CFR 50.56

Answer 14

wards

Question 15

21 CFR 54

Answer 15

financial disclosure of investigators

Question 16

21 CFR 56

Answer 16

IRBs

Question 17

21 CFR 56.106-7

Answer 17

IRB membership

Question 18

21 CFR 56.108-9

Answer 18

IRB functions and operations

Question 19

21 CFR 56.110

Answer 19

expedited review procedures for research involving NO MORE than minimal risk for minor changes in approved research

Question 20

21 CFR 312

Answer 20

procedures and requirements governing the use of investigational new drugs (including IND applications)

Question 21

45 CFR 46

Answer 21

protection of human subjects (HHS)

Question 22

45 CFR 46 subpart A

Answer 22

basic HHS policy for protection of human subjects

Question 23

45 CFR 46 subpart B

Answer 23

additional protections for pregnant women, human fetuses, and neonates

Question 24

45 CFR 46 subpart C

Answer 24

additional protections pertaining to biomedical and behavioral research involving prisoners as subjects

Question 25

45 CFR 46 subpart D

Answer 25

additional protections for children and wards

Question 26

CBER

Answer 26

center for biologics evaluation and research (center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act)

Question 27

3454

Answer 27

certification of financial interests

Question 28

3455

Answer 28

financial disclosure form (55=FF)

Question 29

IDE

Answer 29

investigational device exemption (allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data)

Question 30

483

Answer 30

inspections observations

Question 31

482

Answer 31

notice of inspections

Question 32

3500A

Answer 32

mandatory reporting of adverse events/problems (A= mAndAtory) (medwatch)

Question 33

3500

Answer 33

voluntary reporting of adverse events/problems (medwatch)