1|Page
ACRP-CP Exam Review 2026 – Actual
Questions With Answers
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).
,2|Page
Audit Trail - correct-answer -Documentation that allows reconstruction of the
course of events.
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)
, 3|Page
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.
Direct Access - correct-answer -Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a clinical
trial.
Documentation - correct-answer -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.
Essential Documents - correct-answer -Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the data
produced.
ACRP-CP Exam Review 2026 – Actual
Questions With Answers
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).
,2|Page
Audit Trail - correct-answer -Documentation that allows reconstruction of the
course of events.
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)
, 3|Page
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.
Direct Access - correct-answer -Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a clinical
trial.
Documentation - correct-answer -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.
Essential Documents - correct-answer -Documents which individually and
collectively permit evaluation of the conduct of a study and the quality of the data
produced.
