ACRP-CP EXAM REVIEW QUESTIONS
AND ANSWERS 100% PASS
Adverse Drug Reaction (ADR) - ANS 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) - ANS 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 - ANS 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 - ANS Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS 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)
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, Case Report Form (CRF) - ANS 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 - ANS 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 - ANS 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) - ANS An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - ANS Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - ANS Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - ANS All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that
describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial,
and the actions taken.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
AND ANSWERS 100% PASS
Adverse Drug Reaction (ADR) - ANS 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) - ANS 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 - ANS 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 - ANS Documentation that allows reconstruction of the course of events.
Blinding/Masking - ANS 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)
1 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
, Case Report Form (CRF) - ANS 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 - ANS 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 - ANS 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) - ANS An investigational or marketed product (i.e., active control), or
placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - ANS Adherence to all the trial-related requirements, Good
Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
Direct Access - ANS Permission to examine, analyze, verify, and reproduce any records and
reports that are important to evaluation of a clinical trial.
Documentation - ANS All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that
describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial,
and the actions taken.
2 @COPYRIGHT 2025/2026 ALLRIGHTS RESERVED.
