ACRP-CP EXAM REVIEW QUESTIONS AND ANSWERS
100% CORRECT!!
, Adverse Drug Reaction (ADR) - 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) - 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 - 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 - ANSWER Documentation that allows reconstruction of the course of
events.
Blinding/Masking - 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) - 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 - 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.
100% CORRECT!!
, Adverse Drug Reaction (ADR) - 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) - 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 - 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 - ANSWER Documentation that allows reconstruction of the course of
events.
Blinding/Masking - 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) - 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 - 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.
