ACRP-CP EXAM REVIEW QUESTIONS WITH VERIFIED
ANSWERS; 100% CORRECT; GRADE A
Adverse Drug Reaction (ADR) - correct answer- All noxious and
unintended responses to a medicinal product related to any dose (causal
relationship is at least a reasonable possibility). Regarding marketed
medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of diseases or for modification of
physiological function
Adverse Event (AE) - correct answer- Any untoward medical
occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. (ICH GCP E6 1.2)
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 requirement(s).
Audit Trail - correct answer- Documentation that allows
reconstruction of the course of events.
,Bias - correct answer- The systematic tendency of any factors
associated with the design, conduct, analysis and evaluation of the
results of a clinical trial to make the estimate of a treatment effect
deviate from its true value.
Blind Review - correct answer- The checking and assessment of data
during the period of time between trial completion (the last observation
on the last subject) and the breaking of the blind, for the purpose of
finalizing the planned analysis.
Blinding, Randomization - correct answer- The most important
design techniques for avoiding bias in clinical trials are ____________
and _______________.
Blinding/Masking - correct answer- A procedure in which one or
more parties to the trial are kept unaware of the treatment assignment.
Single-blinding usually refers to the subject(s) being unaware, and
double- blinding usually refers to the subject(s), investigator(s), monitor,
and, in some cases, data analyst(s) being unaware of the treatment
assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF) - correct answer- A printed, optical, or
electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - correct answer- Any investigation in human
subjects intended to discover or verify the clinical, pharmacological
, and/or other pharmacodynamic effects of an investigational product(s),
and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of
an investigational product(s) with the object of ascertaining its safety
and/or efficacy.
Clinical Trial/Study Report - correct answer- A written description of
a trial/study of any therapeutic, prophylactic or diagnostic agent
conducted in human subjects, in which the clinical and statistical
description, presentations, and analysis are fully integrated into a single
report. (ICH GCP E6 1.13)
Comparator (Product) - correct answer- An investigational or
marketed product (i.e., active control), or placebo, used as a reference in
a clinical trial.
Compliance (in relation to trials) - correct answer- Adherence to all
the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements.
Composite variable - correct answer- If a single primary variable
cannot be selected from multiple measurements associated with the
primary objective, another useful strategy is to integrate or combine the
multiple measurements into a single or '___________' variable, using a
pre-defined algorithm.
ANSWERS; 100% CORRECT; GRADE A
Adverse Drug Reaction (ADR) - correct answer- All noxious and
unintended responses to a medicinal product related to any dose (causal
relationship is at least a reasonable possibility). Regarding marketed
medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of diseases or for modification of
physiological function
Adverse Event (AE) - correct answer- Any untoward medical
occurrence in a patient or clinical investigation subject administered a
pharmaceutical product and which does not necessarily have a causal
relationship with this treatment. (ICH GCP E6 1.2)
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 requirement(s).
Audit Trail - correct answer- Documentation that allows
reconstruction of the course of events.
,Bias - correct answer- The systematic tendency of any factors
associated with the design, conduct, analysis and evaluation of the
results of a clinical trial to make the estimate of a treatment effect
deviate from its true value.
Blind Review - correct answer- The checking and assessment of data
during the period of time between trial completion (the last observation
on the last subject) and the breaking of the blind, for the purpose of
finalizing the planned analysis.
Blinding, Randomization - correct answer- The most important
design techniques for avoiding bias in clinical trials are ____________
and _______________.
Blinding/Masking - correct answer- A procedure in which one or
more parties to the trial are kept unaware of the treatment assignment.
Single-blinding usually refers to the subject(s) being unaware, and
double- blinding usually refers to the subject(s), investigator(s), monitor,
and, in some cases, data analyst(s) being unaware of the treatment
assignment(s). (ICH GCP E6 1.10)
Case Report Form (CRF) - correct answer- A printed, optical, or
electronic document designed to record all of the protocol required
information to be reported to the sponsor on each trial subject.
Clinical Trial/Study - correct answer- Any investigation in human
subjects intended to discover or verify the clinical, pharmacological
, and/or other pharmacodynamic effects of an investigational product(s),
and/or to identify any adverse reactions to an investigational product(s),
and/or to study absorption, distribution, metabolism, and excretion of
an investigational product(s) with the object of ascertaining its safety
and/or efficacy.
Clinical Trial/Study Report - correct answer- A written description of
a trial/study of any therapeutic, prophylactic or diagnostic agent
conducted in human subjects, in which the clinical and statistical
description, presentations, and analysis are fully integrated into a single
report. (ICH GCP E6 1.13)
Comparator (Product) - correct answer- An investigational or
marketed product (i.e., active control), or placebo, used as a reference in
a clinical trial.
Compliance (in relation to trials) - correct answer- Adherence to all
the trial-related requirements, Good Clinical Practice (GCP)
requirements, and the applicable regulatory requirements.
Composite variable - correct answer- If a single primary variable
cannot be selected from multiple measurements associated with the
primary objective, another useful strategy is to integrate or combine the
multiple measurements into a single or '___________' variable, using a
pre-defined algorithm.
