21 CFR Part 50

Question 1

Define Clinical Investigation

Answer 1

Experiment that involves a test article and 1 or more human subjects and that either is subject to requirements for prior submission to the FDA or the results of which must be submitted to the FDA

Question 2

Define Investigator

Answer 2

Person who conducts a clinical investigation under whose immediate direction the IMP is administered/dispensed to a subject

The responsible leader of a clinical research team

Question 3

Define Sponsor

Answer 3

Person who initiates a clinical investigation but does not conduct the investigation - the IMP is administered/dispensed under the immediate direction of someone else

An agency that uses 1 or more of its employees to conduct a clinical investigation

Question 4

Define Sponsor-Investigator

Answer 4

Someone who initiates and conducts a clinical investigation - the IMP is dispensed/administered under the immediate direction of this person

Question 5

What is a human subject?

Answer 5

Someone who is or becomes a participant in research either by receiving active study treatment or control study treatment

Can be healthy human or a patient

Question 6

What is an institution?

Answer 6

Public or private entity or agency

Question 7

What is an Institutional Review Board (IRB)?

Answer 7

A formerly designated board/committee/group that reviews biomedical research involving humans as subjects to approve the initiation of and conduct periodic review of that research

Question 8

Define test article

Answer 8

Drug or biologic

Medical device for human u se

Human food additive

Color additive

Electronic product

Or other article subject to regulation under the Public Health Service Act

Question 9

What is minimal risk?

Answer 9

The probability and magnitude of harm/discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine exams/tests

Question 10

What is a legally authorized representative?

Answer 10

A person or judicial body who is able to consent on behalf of a participant as to the participant’s participation in the clinical research/procedure

Question 11

Define assent

Answer 11

a child’s affirmative agreement to participate in clinical research

Question 12

21 CFR Part 50 Subpart B refers to what?

Answer 12

Informed Consent of Human Subjects

Question 13

21 CFR Part 50 Subpart A refers to what?

Answer 13

General provisions for clinical trials

Question 14

The Investigator must obtain ______________ from the subject or the subject’s LAR prior to involving that subject in clinical research

Answer 14

Legally effective informed consent

Question 15

An Investigator should provide the subject or subject’s LAR with ample ____________ to consider whether or not to participate in clinical research

Answer 15

Time

Question 16

An Investigator should minimize the possibility of what during the informed consent process?

Answer 16

Coercion or undue influence

Question 17

The language of the informed consent (document and process) must be _________________ to the subject and subject’s LAR

Answer 17

Understandable and non-technical

Question 18

Informed consents (oral or written) CANNOT waive what?

Answer 18

Subject’s legal rights

The release of the Investigator, Sponsor, or Institution from liability for negligence

Question 19

When must informed consent be obtained from the participant?

Answer 19

Before use of the test article

Question 20

Consent can be forgone prior to administering the test article if the PI and a physician not participating in the clinical investigation can verify in writing all of the following:

Answer 20

a) The subject is confronted by a life-threatening situation that necessitates the use of the test article
b) The subject is unable to communicate
c) There is insufficient time to obtain consent from the subject’s LAR
d) There is no available alternative or generally recognizable methods that will provide an equal or greater likelihood of saving the subject’s life

Question 21

If immediate use of the test article is recommended by the PI and there is insufficient time to obtain a determination from a physician not involved in the clinical trial, the determinations of the PI must be reviewed by ___________________ within _____ working days after use of the test article.

Answer 21

a) a physician who is not involved in the clinical investigation

b) 5

Question 22

If consent is not obtained prior to the use of a test article (as in an emergency situation), how soon must the IRB be notified?

Answer 22

Within 5 working days after the use of the test article

Question 23

True or False: The President can waive the prior consent requirement for the administration of an investigational new drug for a member of the armed forces

Answer 23

True

Question 24

In order for the President to grant a waiver from informed consent (prior to administering investigational new drug), the President must document what?

Answer 24

a) obtaining consent is not feasible

b) obtaining consent is contrary to the best interests of the military member

c) obtaining consent is not in the best interest of national security

Question 25

IRBs can approve investigations without requiring informed consent of all research subjects be obtained if