Question 1

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

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?

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?

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

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?

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?

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?

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

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?

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?

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

Accepted Answer

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

Question 12

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

Accepted Answer

Source documents are defined in GCP as "Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes,…pharmacy dispensing records, recorded data from automated instruments,…photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial)."

Question 13

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

Accepted Answer

The study protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial. The protocol document must contain specific elements.

Question 14

The Food and Drug Administration governs clinical research performed by

Accepted Answer

Clinical research by manufacturers (drugs, devices, and biologicals) is governed by FDA federal code.

Question 15

What are the two categories of clinical trials?

Accepted Answer

Clinical research, or trials, are loosely categorized as either sponsored (e.g., by a pharmaceutical or device company) or investigator initiated (e.g., an investigator plans and conducts a research study).

Question 16

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

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 IRB. 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 17

What is a protocol deviation?

Accepted Answer

The imaging site personnel involved in clinical research are obligated to follow all aspects of the clinical trial protocol, including all imaging procedures that are provided in the imaging manual, and to not deviate from any of those procedures as they are written. However, instances occur when something is out of the imaging staff's control - such as a patient being late for a scanning appointment, or a blood-draw being late because the intravenous line failed. When these things happen, they are considered a protocol deviation: a variation from processes or procedures defined in a protocol.

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

Accepted Answer

A case report form (CRF) is not the same as the source document, and this can be a confusing concept for imaging sites that are new to research. A CRF is defined as "A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject." It is a record of clinical study observations and other information that a study protocol designates must be completed for each subject.

Question 19

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

Accepted Answer

Patient privacy is a serious concern in clinical research. Researchers and sponsors must follow privacy protection rules for research as codified in Parts 160 and 164 of the Health Insurance Portability and Accountability Act.

Question 20

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

Accepted Answer

The study protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of the trial. The protocol document must contain the following elements: a statement of the study objectives and purpose; the criteria for patient inclusion/exclusion as well as an estimate of the number of patients to be studied; a description of the design of the study, including the kind of control group to be used (if any) and a description of methods to be used to minimize bias on the part of subjects, analysts and investigators; method for determining the dose(s) to be administered, the planned maximum dosage and duration of individual exposure to the subject from the study drug; objectives of the study, which include an explanation of observations and measurements to be made; and a description of clinical procedures, laboratory tests or other measures to be taken to monitor the effects of the drug in subjects and to minimize risk.

Quiz 8: Clinical Research