Deck 8: Clinical Research

Question 1

In the U.S., clinical trials must be approved by an independent ethics committee, which is called the

A) Contract Research Organization (CRO).
B) Good Clinical Practice (GPC).
C) Institutional Review Board (IRB).
D) Common Rule.

Answer 1

Institutional Review Board (IRB).

Question 2

Which term is used to denote the type of clinical research that involves the testing of interventions on health-related outcomes?

A) Clinical practice
B) Clinical trial
C) Developmental research
D) Developmental trial

Answer 2

Clinical trial

Question 3

Which of the following is the DHHS Federal Policy for the Protection of Human Subjects?

A) Common Rule
B) Good Clinical Practice
C) HIPAA
D) Institutional Review Board

Answer 3

Common Rule

Question 4

The one individual who is entirely responsible for the conduct of the trial is the

A) lead technologist.
B) protocol supervisor.
C) primary investigator.
D) contracted researcher.

Question 5

What is the code of clinical research practices followed by sponsors and researchers on an international level?

A) HIPAA
B) Good Clinical Practice
C) ALCOA
D) Common Rule

Question 6

Which acronym is used to aid in proper documentation during a clinical trial?

A) IRB
B) GCP
C) CRO
D) ALCOA

Question 7

Which term refers to the entity that accepts all responsibility for regulatory aspects of conducting the trial, including protection of human subjects and data integrity?

A) Principal investigator
B) Primary investigator
C) Clinical research associate
D) Sponsor

Question 8

All of the following are responsibilities of a monitor, EXCEPT

A) obtain the study sponsor.
B) insure the accuracy of the clinical trial data.
C) check for proper informed consent procedures.
D) check for appropriate documentation.

Question 9

Which term is defined as a process whereby the subject is given an opportunity to review all of the study procedures, benefits and risks of the study, and alternative treatment available to them if they choose not to participate in the study?

A) Informed consent
B) Institutional review board
C) Protocol document
D) Source document

Question 10

Which of the following often results in data not deemed evaluable for a protocol analysis?

A) Protocol deviation
B) Protocol violation
C) Study aberration
D) Study eccentricity

Question 11

The protection of rights, safety, and well-being of human subjects is the primary responsibility of the

A) protocol document.
B) primary investigator.
C) Institutional Review Board.
D) monitor.

Question 12

Original medical records used as documentation in a clinical trial are termed

A) protocol documents.
B) research contracts.
C) source documents.
D) investigator notes.

Question 13

A document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial is the

A) informed consent.
B) source document.
C) protocol.
D) contract research organization.

Question 14

The Food and Drug Administration governs clinical research performed by

A) the Department of Agriculture.
B) manufacturers of drugs, devices, and biologicals.
C) the Nuclear Regulatory Agency.
D) all investigators.

Question 15

What are the two categories of clinical trials?

A) Subsidized and investigator initiated
B) Sponsored and independent
C) Sponsored and investigator initiated
D) Subsidized and independent

Question 16

How many members are required to comprise an Institutional Review Board?

A) Three
B) Five
C) Seven
D) Nine

Question 17

What is a protocol deviation?

A) A variation from processes or procedures defined in a protocol
B) A significant departure from the processes or procedures as required by the clinical trial protocol
C) An irrelevant consequence of clinical trial studies
D) An avoidable data breach that invalidates the clinical trial

Question 18

A record of clinical study observations and other information that a study protocol designates that must be completed for each subject is the

A) clinical report form.
B) case report form.
C) source document.
D) monitor report.

Question 19

Researchers and sponsors must follow privacy protection rules for research involving human subjects as codified in the

A) Health Insurance Portability and Accountability Act.
B) Food and Drug Administration, Title 21.
C) Good Clinical Practice.
D) Common Rule.

Question 20

All of the following must be included within the protocol document, EXCEPT

A) purpose and objectives of the study.
B) number of patients to be included in the study.
C) description of the design.
D) expected outcomes of the trial.