CFR

Question 1

21 CFR Part 11

Answer 1

Electronic Records; Electronic signatures

Question 2

21 CFR Part 50

Answer 2

Protection of Human Subjects

Question 3

21 CFR Part 56

Answer 3

Institutional Review Board

Question 4

21 CFR Part 312

Answer 4

Investigational New Drug Application

Question 5

21 CFR Part 812

Answer 5

Investigational Device Exemptions

Question 6

45 CFR Part 46

Answer 6

Public Welfare

Question 7

FDA Form 482

Answer 7

Notice of Inspection

Question 8

FDA Form 483

Answer 8

Inspectional Observations

Question 9

FDA Form 1572

Answer 9

Statement of Investigator

Question 10

FDA Form 3454

Answer 10

Certification - Financial Interests and Arrangements of Clinical Investigators

Question 11

FDA Form 3455

Answer 11

Disclosure - Financial Interests and Arrangements of Clinical Investigators

Question 12

FDA Form 3500

Answer 12

For Volunteer Reporting of Adverse Events and Product Problems

Question 13

FDA Form 3500A

Answer 13

For use by user-facilities, distributors, and manufacturing for mandatory reporting

Question 14

21CRF Part 11 Subpart A

Answer 14

General Provision

Question 15

21CRF Part 11 Subpart B

Answer 15

Electronic Records

Question 16

21CRF Part 11 Subpart C

Answer 16

Electronic signatures

Question 17

21CRF Part 50 Subpart A

Answer 17

General provisions

Question 18

21CRF Part 50 Subpart B

Answer 18

Informed Consent of Human Subjects

Question 19

21CRF Part 50 Subpart C

Answer 19

Additional Safeguards for Children

Question 20

21CRF Part 56 Subpart A

Answer 20

general provision

Question 21

21CRF Part 56 Subpart B

Answer 21

Organization and personnel

Question 22

21CRF Part 56 Subpart C

Answer 22

IRB Functions and operations

Question 23

21CRF Part 56 Subpart D

Answer 23

Records and Reports

Question 24

21CRF Part 56 Subpart E

Answer 24

Administrative actions for noncompliance

Question 25

21CRF Part 312 Subpart A

Answer 25

General provisions

Question 26

21CRF Part 312 Subpart B

Answer 26

IND

Question 27

21CRF Part 312 Subpart C

Answer 27

Administrative actions

Question 28

21CRF Part 312 Subpart D

Answer 28

Responsibilities of sponsors and investigators

Question 29

21CRF Part 312 Subpart E

Answer 29

Drugs intended to treat life-threatening and severely debilitating illnesses

Question 30

21CRF Part 312 Subpart F

Answer 30

Misc

Question 31

21CRF Part 312 Subpart I

Answer 31

Expanded Access to Investigational Drugs for treatment use

Question 32

21CRF Part 812 Subpart A

Answer 32

general provisions

Question 33

21CRF Part 812 Subpart B

Answer 33

Application and administrative action

Question 34

21CRF Part 812 Subpart C

Answer 34

Responsibilities of sponsors

Question 35

21CRF Part 812 Subpart D

Answer 35

IRB review and approval

Question 36

21CRF Part 812 Subpart E

Answer 36

Responsibilities of Investigators

Question 37

21CRF Part 812 Subpart G

Answer 37

Records and reports

Question 38

45CRF Part 46 Subpart A

Answer 38

Basic HHS Policy for Protection of Human Research Subjects

Question 39

45CRF Part 46 Subpart B

Answer 39

Additional Protections for Pregnant women, human fetuses and neonates involved in research

Question 40

45CRF Part 46 Subpart C

Answer 40

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

Question 41

45CRF Part 46 Subpart D

Answer 41

Additional protections for children involved as subjects in research

Question 42

45CRF Part 46 Subpart E

Answer 42

Registration of IRBs

Question 43

Belmont Report

Answer 43

Created by the national commission for the protection of human subjects of biomedical and behavioral research. Describes ethical principles and guidelines for the protection of human subjects

Question 44

Nuremberg Code

Answer 44

Set of 10 ethical principles for human experimentation. The code came about as a result of trials held in Nuremberg, Germany at the end of WWII. Published in the Trials of War Criminals

Question 45

Declaration of Helsinki

Answer 45

Set of ethical principles for medical research involving human subjects. Developed by the World Medical Association.

Question 46

ICH harmonized guidelines for GCP

Answer 46

This GCP document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, and IRBs. GCPs cover aspects of monitoring, reporting, and archiving of clinical trials and incorporating addenda on the essential documents and on the IB which had been agreed earlier through the ICH process