CenterWatch Glossary of Clinical Trials| 100
QUESTIONS| WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: An unintended reaction to a drug taken at doses
normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of
physiological function. In clinical trials, an ADR would include any injuries by overdosing,
abuse/dependence, and unintended interactions with other medicinal products.
Adverse Event (AE) Correct Answer: A negative experience encountered by an individual
during the course of a clinical trial, that is associated with the drug. An AE can include
previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE
has been determined to be related to the investigational product, it is considered an Adverse Drug
Reaction.
Adverse Event Reports Correct Answer: Investigator reports of all serious and adverse events,
injury and deaths given to the sponsor, the IRB and the FDA.
Adverse Reaction Correct Answer: An unwanted effect caused by the administration of drugs.
Onset may be sudden or develop over time.
Advocacy and Support Groups Correct Answer: Organizations and groups that actively support
participants and their families with valuable resources, including self-empowerment and survival
tools.
Approved Drugs Correct Answer: In the U.S., the Food and Drug Administration (FDA) must
approve a substance as a drug before it can be marketed. The approval process involves several
steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy,
filing of a New Drug Application by the manufacturer of the drug, FDA review of the
application, and FDA approval/rejection of application.
ARM Correct Answer: Any of the treatment groups in a randomized trial. Most randomized
trials have two "arms," but some have three "arms," or even more.
Assent Correct Answer: A child's affirmative agreement to participate in a clinical investigation.
Mere failure to object may not, absent affirmative agreement, be construed as assent.
Audit Correct Answer: A systematic and independent examination of trial-related activities and
documents to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), good clinical practice (GCP), and the applicable
regulatory and ethical requirement(s).
Baseline Correct Answer: 1. Information gathered at the beginning of a study from which
variations found in the study are measured. 2. A known value or quantity with which an
unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just
, before a participant starts to receive the experimental treatment which is being tested. At this
reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug
are often determined by monitoring changes from the baseline values.
Belmont Report Correct Answer: A report created by the former United States Department of
Health, Education, and Welfare (which was renamed to Health and Human Services) entitled
"Ethical Principles and Guidelines for the Protection of Human Subjects of Research," authored
by Dan Harms, and is an important historical document in the field of medical ethics. The report
was created on April 18, 1979 and gets its name from the Belmont Conference Center where the
document was drafted. The report continues as an essential reference for institutional review
boards (IRBs) that review HHS-conducted or -supported human subjects research proposals
involving human subjects, in order to ensure that the research meets the ethical foundations of
the regulations.
Bias Correct Answer: When a point of view prevents impartial judgment on issues relating to
the subject of that point of view. In clinical studies, bias is controlled by blinding and
randomization.
Biologic Correct Answer: A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, or analogous product applicable to the prevention,
treatment or cure of diseases or injuries of man.
Biotechnology Correct Answer: Any technique that uses living organisms, or substances from
organisms, biological systems, or processes to make or modify a product or process, to change
plants or animals, or to develop micro-organisms for specific uses.
Blinding Correct Answer: The process through which one or more parties to a clinical trial are
unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware
of the treatment assignments. In a double-blinded study, both the subjects and the investigators
are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and
sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the
unintentional biases that can affect subject data when treatment assignments are known.
Brand Name Drug Correct Answer: A brand name drug is a drug marketed under a proprietary,
trademark-protected name.
Cardiology/Vascular Diseases Correct Answer: Diseases having to do with the structure and
function of the heart and blood vessels. Studies in these areas include: heart failure, coronary
artery disease, high cholesterol, blood clots, circulation disorders, and others.
Case Report Form (CRF) Correct Answer: A record of pertinent information collected on each
subject during a clinical trial, as outlined in the study protocol.
Certified Research Coordinator (CCRC) Correct Answer: CRC with greater than two years
experience and with certification earned by passing required program and exam.
QUESTIONS| WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: An unintended reaction to a drug taken at doses
normally used in man for prophylaxis, diagnosis, or therapy of disease, or for the modification of
physiological function. In clinical trials, an ADR would include any injuries by overdosing,
abuse/dependence, and unintended interactions with other medicinal products.
Adverse Event (AE) Correct Answer: A negative experience encountered by an individual
during the course of a clinical trial, that is associated with the drug. An AE can include
previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE
has been determined to be related to the investigational product, it is considered an Adverse Drug
Reaction.
Adverse Event Reports Correct Answer: Investigator reports of all serious and adverse events,
injury and deaths given to the sponsor, the IRB and the FDA.
Adverse Reaction Correct Answer: An unwanted effect caused by the administration of drugs.
Onset may be sudden or develop over time.
Advocacy and Support Groups Correct Answer: Organizations and groups that actively support
participants and their families with valuable resources, including self-empowerment and survival
tools.
Approved Drugs Correct Answer: In the U.S., the Food and Drug Administration (FDA) must
approve a substance as a drug before it can be marketed. The approval process involves several
steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy,
filing of a New Drug Application by the manufacturer of the drug, FDA review of the
application, and FDA approval/rejection of application.
ARM Correct Answer: Any of the treatment groups in a randomized trial. Most randomized
trials have two "arms," but some have three "arms," or even more.
Assent Correct Answer: A child's affirmative agreement to participate in a clinical investigation.
Mere failure to object may not, absent affirmative agreement, be construed as assent.
Audit Correct Answer: A systematic and independent examination of trial-related activities and
documents to determine whether the evaluated trial-related activities were conducted, and the
data were recorded, analyzed, and accurately reported according to the protocol, sponsor's
standard operating procedures (SOPs), good clinical practice (GCP), and the applicable
regulatory and ethical requirement(s).
Baseline Correct Answer: 1. Information gathered at the beginning of a study from which
variations found in the study are measured. 2. A known value or quantity with which an
unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just
, before a participant starts to receive the experimental treatment which is being tested. At this
reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug
are often determined by monitoring changes from the baseline values.
Belmont Report Correct Answer: A report created by the former United States Department of
Health, Education, and Welfare (which was renamed to Health and Human Services) entitled
"Ethical Principles and Guidelines for the Protection of Human Subjects of Research," authored
by Dan Harms, and is an important historical document in the field of medical ethics. The report
was created on April 18, 1979 and gets its name from the Belmont Conference Center where the
document was drafted. The report continues as an essential reference for institutional review
boards (IRBs) that review HHS-conducted or -supported human subjects research proposals
involving human subjects, in order to ensure that the research meets the ethical foundations of
the regulations.
Bias Correct Answer: When a point of view prevents impartial judgment on issues relating to
the subject of that point of view. In clinical studies, bias is controlled by blinding and
randomization.
Biologic Correct Answer: A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood
component or derivative, allergenic product, or analogous product applicable to the prevention,
treatment or cure of diseases or injuries of man.
Biotechnology Correct Answer: Any technique that uses living organisms, or substances from
organisms, biological systems, or processes to make or modify a product or process, to change
plants or animals, or to develop micro-organisms for specific uses.
Blinding Correct Answer: The process through which one or more parties to a clinical trial are
unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware
of the treatment assignments. In a double-blinded study, both the subjects and the investigators
are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and
sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the
unintentional biases that can affect subject data when treatment assignments are known.
Brand Name Drug Correct Answer: A brand name drug is a drug marketed under a proprietary,
trademark-protected name.
Cardiology/Vascular Diseases Correct Answer: Diseases having to do with the structure and
function of the heart and blood vessels. Studies in these areas include: heart failure, coronary
artery disease, high cholesterol, blood clots, circulation disorders, and others.
Case Report Form (CRF) Correct Answer: A record of pertinent information collected on each
subject during a clinical trial, as outlined in the study protocol.
Certified Research Coordinator (CCRC) Correct Answer: CRC with greater than two years
experience and with certification earned by passing required program and exam.
