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11 Cards in this Set
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- Back
- 3rd side (hint)
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Jeff Washington works for the Acme Device Company, the sponsor of a new clinical trial named CLEAR2. He has just been appointed as Clinical Trial Manager for the CLEAR2 study.
Which of the following best describes Jeff’s role in the CLEAR2 study? A. Jeff guides clinical aspects of the trial. B. Jeff oversees the operational execution of the trial. C. Jeff focuses his time onsite at particular study sites, ensuring data is captured correctly. |
Correct Answer: Jeff guides clinical aspects of the trial.
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Jeff guides clinical aspects of the trial. The Clinical Trial Manager (also referred to as Clinical Scientist) serves as the clinical lead on a study. While the Clinical Trial Manager may or may not be a physician, this person usually has significant medical and research experience and guides clinical aspects of the trial. The Clinical Trial Manager is also typically responsible for the entire development program for the product, not just an individual trial.
Typically, the Project Manager, not the Clinical Trial Manager, oversees the operational execution of the trial. The Clinical Research Associate (CRA), not the Clinical Trial Manager, conducts onsite monitoring visits, and during these visits one of their responsibilities is to ensure data are captured correctly. |
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You are the Clinical Research Coordinator (CRC) at a study site. You receive a batch of lab results from the central lab for the study and note that one subject’s date of birth does not appear to match the date of birth on the medical record for that subject at your site.
Whom should you contact at the central lab to rectify this discrepancy? A. The Help Desk B. The Medical Director C. The Project Manager |
Correct Answer: The Help Desk
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You would most likely contact the Help Desk at the central lab first, to rectify this administrative discrepancy. Most central labs have a help desk that is responsible for answering questions, solving lab issues and resupplying lab materials. Refer to the Lab Manual provided by the central lab for your trial to find specific contact information.
The Project Manager is responsible for ensuring that the study progresses from the central lab standpoint. The Medical Director has the responsibility of overseeing the entire central lab. These staff members would not likely be responsible for administrative issues and would generally delegate tasks such as verifying a date of birth to the help desk. |
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Both Sponsors and Contract Research Organizations/Academic Research organizations (CRO/AROs) employ Project Managers (PMs), Medical Monitors, and Clinical Research Associates (CRAs) to conduct clinical trials.
How do the roles of these individuals at the Sponsor differ from those at the CRO/ARO? A. The individuals at the Sponsor organization generally have a less significant role in the study than at the CRO/ARO. B. All of these individuals have the same role at the Sponsor as they do at the CRO/ARO. C. The individuals at the Sponsor generally have a more significant role on the study than at the CRO/ARO. |
Correct Answer: All of these individuals have the same role at the Sponsor as they do at the CRO/ARO.
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All of these individuals have the same role at the Sponsor as they do at the CRO/ARO; it is just a matter of whether the Sponsor chooses to contract out these functions to a CRO/ARO or to perform these functions themselves.
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A drug’s safety is determined by which of the following criteria?
A. The dose at which no side effects are reported B. The absence of harmful side effects on the individuals exposed to it so far C. The Food and Drug Administration’s (FDA) review of source documentation at a clinical site |
Correct Answer: The absence of harmful side effects on the individuals exposed to it so far
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The absence of harmful side effects on the individuals exposed to a drug so far is the measure by which a drug’s safety is determined.
It is virtually impossible to prove that a drug or a device is truly safe; however, it can be shown to have an absence of harmful side effects. Even under the best conditions, clinical trials only test a sample of the population for a relatively short period and cannot fully predict what will occur in a more diverse population or over longer periods. Drugs and devices must be carefully designed and assessed to ensure an absence of harmful side effects resulting from the product. It would be unusual for a drug to have no side effects reported with it during the clinical trial process. However, it may be determined that the side effects reported were not clinically significant or not related to the study treatment. In these cases, the drug may be determined to be “safe” despite the side effects reported at the dose being tested and approved. The FDA does not review source documentation at a clinical site except in the situation of an audit. A drug safety determination would not result solely from a site audit. |
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Which of the following statements best defines the term “efficacy” in a clinical trial?
A. The best possible outcome of a clinical trial B. The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease C. A determination proving there is a statistically significant difference in the pharmacokinetic effect of the study drug versus placebo |
Correct Answer: The capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease
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Efficacy is determined by the capacity of a drug or treatment to produce beneficial effects on the course or duration of a disease, at the dose tested and against the illness and patient population for which it is designed. In laymen’s terms, does the drug do what it’s supposed to do?
The term “best possible outcome” is not the best definition of efficacy in clinical trials; it better describes the desired outcome of the trial itself. A measure of efficacy would be needed to determine if the best possible outcome was achieved. Pharmacokinetics is the study of the processes of bodily absorption, distribution, metabolism, and excretion (ADME) of compounds and medications and may or may not be directly related to efficacy. |
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Which of the following terms is best defined as "a pharmaceutical preparation that contains no active agent”?
A. Blinded B. Non-invasive C. Placebo |
Correct Answer: Placebo
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Placebo is a pharmaceutical preparation that contains no active agent.
A common misconception about placebos in pill form is that they are “sugar-pills.” There is actually no sugar in most placebos. They are typically made of inert ingredients and are often lactose based. The term “blinded” refers to a technique used to help eliminate bias in clinical research. “Non-invasive” is a term used to describe a procedure or device that does not require entering the body or puncturing the skin. |
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Which of the following design methods would best be used for a study interested in keeping both the subject and the Investigator (or site staff) from knowing which treatment the subject is receiving?
A. Double blind B. Interpretive bias C. Bias reduction |
Correct Answer: Double blind
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The Double blind study design method ensures the subject and the Investigator (or site staff) do not know which treatment the subject is receiving.
In a clinical trial the blinded individual or agency does not know what treatment (or placebo) the subject is assigned. There are several levels of blinding: Single: Subject does not know the treatment group to which he/she is assigned. Double: Subject and the treating clinician/research team do not know the treatment group. Triple: Subject, the treating clinician/research team, and the trial monitoring committee (e.g., Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)) do not know the treatment group. In both double and triple-blinded studies, typically the Sponsor and their designees also do not know the actual treatment assignments made to each subject until all of the data has been gathered. There can be exceptions to this depending on the trial. Reduction of bias is the goal of using blinding methods. It is not a specific study design method. Interpretive bias is not a study design method, but rather, something that should be avoided in clinical research studies. Interpretive bias can result when blinding methods for a study are not sufficient to prevent an individual or group from making conclusions based on a subject’s treatment assignment. |
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Which person(s) or agency would not be informed of the treatment assignment for a given subject in a study that was using a single blind method of randomization?
A. The subject B. The treating clinician/research team C. The FDA |
Correct Answer: The subject
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The subject would not be informed of the treatment assignment in a study that was using a single blind method of randomization.
In a clinical trial the blinded individual or agency does not know what treatment (or placebo) the subject is assigned. There are several levels of blinding: Single: Subject does not know the treatment group to which he/she is assigned. Double: Subject and the treating clinician/research team do not know the treatment group. Triple: Subject, the treating clinician/research team, and the trial monitoring committee (e.g., Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC)) do not know the treatment group. In both double and triple-blinded studies, typically the Sponsor and their designees also do not know the actual treatment assignments made to each subject until all of the data has been gathered. There can be exceptions to this depending on the trial. The treating clinician/research team would have access to the treatment assignment information for subjects enrolled in a single blind trial. In a single blind study design, it is only important for the subject to remain blinded to their treatment assignment. Therefore, the FDA could have access to this information. |
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What is the primary reason for blinding individuals or groups to the assigned treatments in a clinical trial?
A. It decreases the amount of unnecessary data collection B. It is intended to eliminate bias C. It is the only way to ensure accurate results |
Correct Answer: It is intended to eliminate bias
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Blinding is important in clinical trials for many reasons but primarily it is intended to eliminate bias.
Blinding the treating clinician/research team helps to eliminate bias in follow-up/data collection and outcome assessment between intervention and control groups (i.e., observation bias). Blinding the subject helps eliminate bias in adherence and patient reporting of symptoms during follow-up/data collection (i.e., reporting bias). Blinding the Data Safety Monitoring Board (DSMB) helps eliminate bias in interpretation of findings (i.e., interpretation bias or analytic bias). While blinding significantly impacts the quality of data, it does not directly correlate to the amount of data being collected. Blinding participants in a clinical trial helps eliminate bias in adherence and patient reporting of symptoms during follow-up/data collection (i.e., reporting bias), but it is not the only way to ensure accurate results. |
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Advisory Committees were designed by the Food and Drug Administration (FDA) to enhance the drug review and approval process. FDA Advisory Committees review applications for the approval to market drugs.
Which of the following is an example of an FDA Advisory Committee? A. Oncologic Drugs Advisory Committee B. Rocky Mountain Advisory Committee C. Pfizer Pharmaceutical Advisory Committee |
Correct Answer: Oncologic Drugs Advisory Committee
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FDA Advisory Committees are organized by indication. As such, the Oncologic Drugs Advisory Committee is an example of one of these committees. Other examples include the Cardiovascular and Renal Drugs Advisory Committee, the Gastrointestinal Drugs Advisory Committee, and the Psychopharmacologic Drug Advisory Committee.
FDA Advisory Committees are not organized according to pharmaceutical company. As such, the Pfizer Pharmaceutical Advisory Committee is not a valid example. FDA Advisory Committees are not organized by geography. As such, the Rocky Mountain Advisory Committee is not a valid example. |
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Which of the following responsibilities falls under the jurisdiction of the Food and Drug Administration (FDA)?
A. Oversight of regulation adherence in clinical trials B. Approval of individual study sites in clinical trials C. Direct management of clinical trials |
Correct Answer: Oversight of regulation adherence in clinical trials
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The FDA is responsible for the oversight of regulation adherence in clinical trials.
Additionally, the FDA is the governing agency to which Sponsors apply for approval to study and market new drugs and, in some cases, devices. Direct management of clinical studies is performed by the Sponsor or a Contract Research Organization (CRO) or Academic Research Organization (ARO) contracted by the Sponsor. Individual study site approval is the responsibility of the Sponsor or CRO/ARO contracted by the Sponsor and the Institutional Review Board (IRB). |
