US Code of Federal Regulations

Question 1

HHS: Title 45 CFR Part 46

Answer 1

Policy for Protection of Human Research Subjects-Common Rule

Question 2

Title 21 CFR Part 11

Answer 2

Electronic Records, Signature

Question 3

Title 21 CFR Part 50

Answer 3

Informed Consent

Question 4

Title 21 CFR Part 54

Answer 4

Financial Disclosure

Question 5

Title 46 CFR Part 56

Answer 5

Institutional Review Boards

Question 6

Title 21 CFR Part 312

Answer 6

Investigational New Drug Application

Question 7

Title 21 CFR Part 812

Answer 7

Investigational Device Exemption

Question 8

Public Health: Title 42 Part 11

Answer 8

Clinical Trials Registration and Results Submission

Question 9

General requirements for informed consent

Answer 9

45 CFR 46.116 & 21 CFR 50.20

Question 10

IRB Membership Requirements

Answer 10

45 CFR 46.107 & 21 CFR 56.107

Question 11

IRB Functions and Operations

Answer 11

45 CFR 46.108 & 21 CFR 56.108

Question 12

Criteria for IRB Approval of Research

Answer 12

45 CFR 46.111 & 21 CFR 56.111

Question 13

Review by Institution

Answer 13

45 CFR 46.112 & 21 CFR 56.112

Question 14

21 CFR Part 803

Answer 14

Medical Device Reporting

Question 15

21 CFR Part 812

Answer 15

Investigational Device Exemption (counterpart to IND requirements 21 CFR 312

Question 16

21 CFR Part 820

Answer 16

Quality Systems Regulations (counterpart to GMP requirements)

Question 17

21 CFR 814

Answer 17

Premarket Approval of Medical Devices (counterpart to NDA requirements 21 CFR 314)

Question 18

21 CFR Part 860

Answer 18

Medical Device Classification Procedures

Question 19

42 CFR 11

Answer 19

ClinicalTrials.gov
*Applicable Clinical Trial ACT includes interventional studies (with one or more arms) of clinical trials including health-related outcomes, drug, biologic, or device products

Question 20

21 CFR 312.60-312.70

Answer 20

Investigator’s Responsibilities

Question 21

312 subpart D, 812 subpart E

Answer 21

Investigator’s responsibilities

Question 22

21 CFR 312.64

Answer 22

Investigator’s responsibility to report adverse events during the study

Question 23

21 CFR 312.62

Answer 23

Maintain adequate and accurate records

Question 24

21 CFR 312.68

Answer 24

Make study records available for inspection

Question 25

Financial Disclosure by Clinical Investigators

Answer 25

21 CFR 54

Question 26

Financial Interest and Arrangements of Clinical Investigators (Form FDA 3454)

Answer 26

This is for clinical investigators who have no disclosable financial interest in or arrangements with the sponsor of the covered clinical study

Question 27

Financial Interests and Arrangements of Clinical Investigators (Form FDA 3455)

Answer 27

The named individual has participated in financial arrangements or holds financial interests that are required to be disclosed as follows:

The form should include an attachment with detailed information about the financial interest and arrangements and a description of the steps taken to minimize the potential for bias.

Question 28

21 CFR 56 & 45 CFR 46

Answer 28

Institutional Review Board

Question 29

21 CFR 50; ICH E6, Sec. 4.8 and 45 CFR 46

Answer 29

Informed Consent

Question 30

General Requirements for informed consent

Answer 30

21 CFR 50.20 & 45 CFR 46.116 and 45 CFR 46.117

Question 31

Exception from general requirements

Answer 31

21 CFR 50.23

Question 32

Exception from informed consent requirements for emergency research

Answer 32

21 CFR 50.25

Question 33

Additional protections for pregnant women, human fetuses, and neonates involved in research

Answer 33

45 CFR 46 Subpart B

Question 34

Elements of informed consent

Answer 34

21 CFR 50.25

Question 35

Additional protections about biomedical and behavioral research involving prisoners as subjects

Answer 35

45 CFR 46 Subpart c

Question 36

Documentation of informed consent

Answer 36

21 CFR 50.27

Question 37

Additional protections for children involved as subjects in research

Answer 37

45 CFR 46 Subpart D

Question 37

Additional safeguards for children in clinical investigations

Answer 37

21 CFR 50 Subpart D

Question 37

Waiver of written consent

Answer 37

45 CFR 46.117(c) and 21 CFR 56.109(c)(1)
-The research involves no more than minimal risk to the subjects
-Linking research to the subject would present a potential farm
-IRB may require providing written information to the subject

Question 38

45 CFR 46

Answer 38

Names vulnerable populations: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons

Question 39

21 CFR 56

Answer 39

Names vulnerable populations: children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons

Question 40

What is the definition of “Child”

Answer 40

21 CFR 50.3 & 45 CFR 46.402

Persons who have not attained the legal age or consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted

Question 41

Parental Permission

Answer 41

21 CFR 50.3 and 45 CFR 46.402

Question 42

21 CFR 314

Answer 42

New Drug Application

Question 43

Part 11

Answer 43

Electronic Records; Electronic Signature

Question 44

Part 50

Answer 44

Protection of Human subjects

Question 45

Part 56

Answer 45

Institutional Review Board

Question 46

Part 312

Answer 46

Investigational New Drug Application

Question 47

Part 812

Answer 47

Investigational Device Exemptions

Question 48

21 CFR 11 Subpart A

Answer 48

Electronic records, electronic signature
Subpart A-General Provisions
§11.1 Scope.
§11.2 Implementation.
§11.3 Definitions.

Question 49

21 CFR 11 Subpart B

Answer 49

Electronic records, electronic signature
§11.10 Controls for closed systems.
§11.30 Controls for open systems.
§11.50 Signature manifestations.
§11.70 Signature/record linking.

Question 50

21 CFR 11 Subpart C

Answer 50

Electronic records, electronic signature
§11.100 General requirements.
§11.200 Electronic signature components and controls.
§11.300 Controls for identification codes/passwords.

Question 51

21 CFR 50 Subpart A

Answer 51

Protection of Human Subjects
§50.1 Scope.
§50.3 Definitions.

Question 52

21 CFR 50 Subpart B

Answer 52

Informed Consent of Human Subjects
§50.20 General requirements for informed consent.
§50.23 Exception from general requirements.
§50.24 Exception from informed consent requirements for emergency research.
§50.25 Elements of informed consent.
§50.27 Documentation of informed consent.

Question 53

21 CFR 50 Subpart D

Answer 53

Additional Safeguards for Children in Clinical Investigations
§50.50 IRB duties.
§50.51 Clinical investigations not involving greater than minimal risk.
§50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual
subjects.
§50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely
to yield generalizable knowledge about the subjects’ disorder or condition.
§50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious
problem affecting the health or welfare of children.
§50.55 Requirements for permission by parents or guardians and for assent by children.
§50.56 Wards.