General Questions

Question 1

minimum number of IRB members

Answer 1

at least five members with varying backgrounds to promote complete and adequate review of the research activities commonly conducted by the institution;

Question 2

In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval?

Answer 2

In a non-emergency situation, subjects cannot be enrolled until IRB/IEC approval has been obtained

Question 3

The responsibility for ensuring that the investigator understands a clinical trial lies with:

Answer 3

The Sponsor

Question 4

CFR

Answer 4

Code of Federal Regulations

Question 5

21 CFR part 11 covers

Answer 5

Electronic Records and electronic signatures

Question 6

21 CFR part 50 covers

Answer 6

protection of human subjects

Question 7

21 CFR part 56 covers

Answer 7

IRB

Question 8

21 CFR part 312 covers

Answer 8

Investigational New Drug Application (IND)

Question 9

21 CFR part 812 covers

Answer 9

Investigational Device Exemptions (IDE)

Question 10

minimal risk

Answer 10

the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Question 11

LAR (legally Authorized Representative)

Answer 11

an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research

Question 12

assent

Answer 12

child’s affirmative agreement to participate in a clinical investigation. Mere failure to object should not, absent affirmative agreement, be construed as assent

Question 13

The World Medical Association (WMA) ethical principles for medical research involving human subjects is called

Answer 13

The Declaration of Helskinki

Question 14

The international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects is known as

Answer 14

Good Clinical Practices (GCP)

Question 15

The Code of Federal Regulations that applies to IRBs

Answer 15

21CFR56

Question 16

The FDA may waive the requirements contained in the regulations, including the requirements for IRB review (true or false)

Answer 16

True

Question 17

Emergency use of a test article is exempt from the requirement for IRB review, provided that such emergency use is reported to the IRB in writing within 5 calendar days (true or false)

Answer 17

False (no timeframe is specified)

Question 18

A clinical hold is an order by FDA to the investigator to suspend or stop ongoing investigations

Answer 18

False (it is an order to the sponsor, not the investigator)

Question 19

what is covered by 21CFR50 subpart B

Answer 19

Informed consent of human subjects

Question 20

What is covered by 45CFR45 subpart B

Answer 20

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

Question 21

per 21 CFR part 312 the sponsor must notify FDA and all participating investigators in an IND safety report within 15 calendar days after the sponsor determines that the information qualifies for reporting (true or false)

Answer 21

True

Question 22

The clinical investigator will update the financial disclosure information if any relevant changes occur during the investigation’s course and for_____________ following the study’s completion

Answer 22

1 year

Question 23

FDA Form 3455

Answer 23

disclosure of financial interests

Question 24

FDA Form 3454

Answer 24

Certification of financial interests

Question 25

IND Application form 1571

Answer 25

submitted by sponsor to FDA prior to the beginning of a drug trial

Question 26

FDA Form 3500

Answer 26

Adverse Event Form

Question 27

FDA Form 3500A

Answer 27

medical device AE/problems form

Question 28

What are the applications for the Belmont Report

Answer 28

1) Informed Consent, 2) Assessment of Risk and Benefits, 3) Selection of Subjects

Question 29

Phase 3 clinical drug trials

Answer 29

1000s of subjects, safety and effectiveness, different populations and doses, uses of the drug in combination with other drugs

Question 30

phase 1 clinical drug trial

Answer 30

20-80 subjects, healthy volunteers, emphasis is safety

Question 31

phase 2 clinical drug trial

Answer 31

100s of subjects, emphasizes effectiveness

Question 32

phase 4 clinical trial

Answer 32

post marketing. monitors safety. role is to detect serious unexpected AEs

Question 33

21 CFR 50 subpart D

Answer 33

additional safeguards for children

Question 34

FDA Form 3454

Answer 34

certification of the absence of financial interest

Question 35

45 CFR 46

Answer 35

HSS regulations for the protection of human subjects in research. Includes 5 subparts

Question 36

45 CFR 46 subpart A

Answer 36

The Common Rule, a robust set of protections for research subjects

Question 37

45 CFR subpart B

Answer 37

additional protections for research with preganant women and fetuses

Question 38

45 CFR subpart C

Answer 38

additional protections for research with prisoners

Question 39

45 CFR subpart D

Answer 39

additional protections for research with children

Question 40

45 CFR subpart E

Answer 40

requirements for IRB registration

Question 41

FDA form 482

Answer 41

notice of inspection

Question 42

FDA form 483

Answer 42

inspection observations

Question 43

unexpected fatal or life threatening SAE associated with drug must be reported to FDA

Answer 43

no later than 7 calendar days after initial receipt of SAE

Question 44

unexpected SAEs for IND trials must be reported to FDA

Answer 44

within 15 calendar days after initial receipt

Question 45

according to ICH guidelines, IRB must retain records for

Answer 45

3 years

Question 46

Purpose of the Belmont Report (1979)

Answer 46

provide basic ethical principles and boundaries between practice and research

Question 47

Practice

Answer 47

interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success

Question 48

Research

Answer 48

an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge

Question 49

ethical convictions of "respect for persons"

Answer 49

individuals should be treated as autonomous agents and persons with diminished autonomy are entitled to protection

Question 50

2 rules that express beneficence

Answer 50

1) do no harm, 2) maximize possible benefits and minimize possible harms

Question 51

5 formulations of justice (just ways to distribute burdens and benefits)

Answer 51

1) to each person an equal share; 2) to each person according to individual need; 3) to each person according to individual effort; 4) to each person according to societal contribution; and 5) to each person according to merit

Question 52

applications outlined in the Belmont Report

Answer 52

1) informed consent--relates to respect for persons 2) assessment of risks and benefits--relates to beneficence 3) selection of subjects--relates to justice