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Terms in this set (89)
All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at
least a reasonable possibility). Regarding marketed
Adverse Drug Reaction medicinal products: a response to a drug which is
(ADR) 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
Any untoward medical occurrence in a patient or
clinical investigation subject administered a
Adverse Event (AE) pharmaceutical product and which does not
necessarily have a causal relationship with this
treatment. (ICH GCP E6 1.2)
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
Audit
and accurately reported according to the protocol,
sponsor's standard operating procedures (SOPs),
Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
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Documentation that allows reconstruction of the
Audit Trail
course of events.
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
Blinding/Masking 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)
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
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
Clinical Trial/Study
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.
A written description of a trial/study of any
therapeutic, prophylactic or diagnostic agent
Clinical Trial/Study Report 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)
An investigational or marketed product (i.e., active
Comparator (Product) control), or placebo, used as a reference in a clinical
trial.
Adherence to all the trial-related requirements, Good
Compliance (in relation to
Clinical Practice (GCP) requirements, and the
trials)
applicable regulatory requirements.
Permission to examine, analyze, verify, and reproduce
Direct Access any records and reports that are important to
evaluation of a clinical trial.
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All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and
Documentation 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.
Documents which individually and collectively permit
Essential Documents evaluation of the conduct of a study and the quality of
the data produced.
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
A person, who is independent of the trial, who cannot
be unfairly influenced by people involved with the
trial, who attends the informed consent process if the
Impartial Witness subject or the subject's legally acceptable
representative cannot read, and who reads the
informed consent form and any other written
information supplied to the subject.
A process by which a subject voluntarily confirms his
or her willingness to participate in a particular trial,
after having been informed of all aspects of the trial
Informed Consent that are relevant to the subject's decision to
participate. Informed consent is documented by
means of a written, signed and dated informed
consent form.
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ACRP-CP Exam Review (2025) UPDATE Verified
Questions And Answers | With 100% Correct
Answers graded A+ Guaranteed Success!!
Save
Terms in this set (89)
All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at
least a reasonable possibility). Regarding marketed
Adverse Drug Reaction medicinal products: a response to a drug which is
(ADR) 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
Any untoward medical occurrence in a patient or
clinical investigation subject administered a
Adverse Event (AE) pharmaceutical product and which does not
necessarily have a causal relationship with this
treatment. (ICH GCP E6 1.2)
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
Audit
and accurately reported according to the protocol,
sponsor's standard operating procedures (SOPs),
Good Clinical Practice (GCP), and the applicable
regulatory requirement(s).
https://quizlet.com/1084369449/acrp-cp-exam-review-2025-update-verified-questions-and-answers-with-100-correct-answers-graded-a-guaranteed-s… 1/16
,9/29/25, 5:49 PM ACRP-CP Exam Review (2025) UPDATE Verified Questions And Answers | With 100% Correct Answers graded A+ Guaranteed Su…
Documentation that allows reconstruction of the
Audit Trail
course of events.
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
Blinding/Masking 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)
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
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
Clinical Trial/Study
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.
A written description of a trial/study of any
therapeutic, prophylactic or diagnostic agent
Clinical Trial/Study Report 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)
An investigational or marketed product (i.e., active
Comparator (Product) control), or placebo, used as a reference in a clinical
trial.
Adherence to all the trial-related requirements, Good
Compliance (in relation to
Clinical Practice (GCP) requirements, and the
trials)
applicable regulatory requirements.
Permission to examine, analyze, verify, and reproduce
Direct Access any records and reports that are important to
evaluation of a clinical trial.
https://quizlet.com/1084369449/acrp-cp-exam-review-2025-update-verified-questions-and-answers-with-100-correct-answers-graded-a-guaranteed-s… 2/16
, 9/29/25, 5:49 PM ACRP-CP Exam Review (2025) UPDATE Verified Questions And Answers | With 100% Correct Answers graded A+ Guaranteed Su…
All records, in any form (including, but not limited to,
written, electronic, magnetic, and optical records, and
Documentation 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.
Documents which individually and collectively permit
Essential Documents evaluation of the conduct of a study and the quality of
the data produced.
A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
Good Clinical Practice reporting of clinical trials that provides assurance that
(GCP) the data and reported results are credible and
accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
A person, who is independent of the trial, who cannot
be unfairly influenced by people involved with the
trial, who attends the informed consent process if the
Impartial Witness subject or the subject's legally acceptable
representative cannot read, and who reads the
informed consent form and any other written
information supplied to the subject.
A process by which a subject voluntarily confirms his
or her willingness to participate in a particular trial,
after having been informed of all aspects of the trial
Informed Consent that are relevant to the subject's decision to
participate. Informed consent is documented by
means of a written, signed and dated informed
consent form.
https://quizlet.com/1084369449/acrp-cp-exam-review-2025-update-verified-questions-and-answers-with-100-correct-answers-graded-a-guaranteed-s… 3/16
