Question 1

In the U.S., clinical trials must be approved by an independent ethics committee, which is called the&#10;A) Contract Research Organization (CRO).&#10;B) Good Clinical Practice (GPC).&#10;C) Institutional Review Board (IRB).&#10;D) Common Rule.

Accepted Answer

It is also the responsibility of the investigator to ensure that the study and ICF are reviewed and approved by an independent ethics committee, known in the US as the Institutional Review Board (IRB) (9). Academic medical centers typically have an IRB, but there are also private IRBs that can be used for non-academic sites that are not affiliated with a university. The required constitution and operation of an IRB is prescribed in 21CFR54.

Question 2

Which term is used to denote the type of clinical research that involves the testing of interventions on health-related outcomes?&#10;A) Clinical practice&#10;B) Clinical trial&#10;C) Developmental research&#10;D) Developmental trial

Accepted Answer

Types of clinical research that involve the testing of interventions on health-related outcomes are termed clinical trials or clinical studies.

Question 3

Which of the following is the DHHS Federal Policy for the Protection of Human Subjects?&#10;A) Common Rule&#10;B) Good Clinical Practice&#10;C) HIPAA&#10;D) Institutional Review Board

Accepted Answer

The DHHS Federal Policy for the Protection of Human Subjects, known as the "Common Rule," is codified in regulations governing 15 federal agencies including the Department of Agriculture, Department of Defense, and the National Science Foundation. The Common Rule regulates research that is conducted by these federal agencies such as studies involving US military personnel, and/or that receive government funding such as an academic institution (e.g., cancer institute) that receives federal grant money. The Common Rule is described in the Code of Federal Regulations (CFR) Title 45 Part 46: Protection of Human Subjects.

Question 4

The one individual who is entirely responsible for the conduct of the trial is the&#10;A) lead technologist.&#10;B) protocol supervisor.&#10;C) primary investigator.&#10;D) contracted researcher.

Accepted Answer

An investigator (sometimes referred to as principal or primary investigator) is an individual under whose authority the clinical trial takes place. This one individual is entirely responsible for the conduct of the trial, but he/she can delegate study tasks to other individuals.

Question 5

What is the code of clinical research practices followed by sponsors and researchers on an international level?&#10;A) HIPAA&#10;B) Good Clinical Practice&#10;C) ALCOA&#10;D) Common Rule

Accepted Answer

In addition to the US Code of Federal Regulations, there is another code of practice that is followed by sponsors and researchers on an international level. This code is called Good Clinical Practice (GCP), and was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, generally referred to simply as ICH.

Question 6

Which acronym is used to aid in proper documentation during a clinical trial?&#10;A) IRB&#10;B) GCP&#10;C) CRO&#10;D) ALCOA

Accepted Answer

This acronym stands for Attributable, Legible, Contemporaneous, Original, and Accurate and is an effective way to develop excellent "documentation hygiene" during clinical research.

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?&#10;A) Principal investigator&#10;B) Primary investigator&#10;C) Clinical research associate&#10;D) Sponsor

Accepted Answer

The sponsor is the entity that accepts all responsibility for regulatory aspects of conducting the trial, including protection of human subjects and data integrity.

Question 8

All of the following are responsibilities of a monitor, EXCEPT&#10;A) obtain the study sponsor.&#10;B) insure the accuracy of the clinical trial data.&#10;C) check for proper informed consent procedures.&#10;D) check for appropriate documentation.

Accepted Answer

Monitors are hired by either the sponsor or the CRO, and have deep expertise in GCP and clinical trial regulations. Their primary function is to ensure the integrity and accuracy of clinical trial data, which includes checking that all informed consent procedures were conducted and documented appropriately, all study procedures were followed as directed in the protocol, and that everything in the CRF is documented in an original source.

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

Accepted Answer

Informed consent is 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. The requirements of the informed consent form (ICF) are documented in 21CFR50, and include elements such as privacy, whom to contact if the subject has questions, and the right to refuse participation in the study.

Question 10

Which of the following often results in data not deemed evaluable for a protocol analysis?&#10;A) Protocol deviation&#10;B) Protocol violation&#10;C) Study aberration&#10;D) Study eccentricity

Accepted Answer

A protocol violation is a more serious concern - when there is a significant departure from the processes or procedures as required by the clinical trial protocol. A protocol violation often results in data not deemed evaluable for a protocol analysis.

Question 11

The protection of rights, safety, and well-being of human subjects is the primary responsibility of the&#10;A) protocol document.&#10;B) primary investigator.&#10;C) Institutional Review Board.&#10;D) monitor.

Accepted Answer

The answer of The protection of rights, safety, and well-being...

Question 12

Original medical records used as documentation in a clinical trial are termed&#10;A) protocol documents.&#10;B) research contracts.&#10;C) source documents.&#10;D) investigator notes.

Accepted Answer

The answer of Original medical records used as documentation in...

Question 13

A document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial is the&#10;A) informed consent.&#10;B) source document.&#10;C) protocol.&#10;D) contract research organization.

Accepted Answer

The answer of A document that describes the objective(s), design,...

Question 14

The Food and Drug Administration governs clinical research performed by&#10;A) the Department of Agriculture.&#10;B) manufacturers of drugs, devices, and biologicals.&#10;C) the Nuclear Regulatory Agency.&#10;D) all investigators.

Accepted Answer

The answer of The Food and Drug Administration governs clinical...

Question 15

What are the two categories of clinical trials?&#10;A) Subsidized and investigator initiated&#10;B) Sponsored and independent&#10;C) Sponsored and investigator initiated&#10;D) Subsidized and independent

Accepted Answer

The answer of What are the two categories of clinical...

Question 16

How many members are required to comprise an Institutional Review Board?&#10;A) Three&#10;B) Five&#10;C) Seven&#10;D) Nine

Accepted Answer

The answer of How many members are required to comprise...

Question 17

What is a protocol deviation?&#10;A) A variation from processes or procedures defined in a protocol&#10;B) A significant departure from the processes or procedures as required by the clinical trial protocol&#10;C) An irrelevant consequence of clinical trial studies&#10;D) An avoidable data breach that invalidates the clinical trial

Accepted Answer

The answer of What is a protocol deviation?&#10;A) A variation...

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&#10;A) clinical report form.&#10;B) case report form.&#10;C) source document.&#10;D) monitor report.

Accepted Answer

The answer of A record of clinical study observations and...

Question 19

Researchers and sponsors must follow privacy protection rules for research involving human subjects as codified in the&#10;A) Health Insurance Portability and Accountability Act.&#10;B) Food and Drug Administration, Title 21.&#10;C) Good Clinical Practice.&#10;D) Common Rule.

Accepted Answer

The answer of Researchers and sponsors must follow privacy protection...

Question 20

All of the following must be included within the protocol document, EXCEPT&#10;A) purpose and objectives of the study.&#10;B) number of patients to be included in the study.&#10;C) description of the design.&#10;D) expected outcomes of the trial.

Accepted Answer

The answer of All of the following must be included...

Deck 8: Clinical Research