ACRP-CP Exam Review Verified Exam Questions and Answers Latest
update 2026/2027
Question:
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
Question:
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)
Question:
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).
Question:
Audit Trail
Answer:
Documentation that allows reconstruction of the course of events.
Question:
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)
,Question:
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.
Question:
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.
Question:
Clinical Trial/Study Report
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)
Question:
Comparator (Product)
Answer:
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a
clinical trial.
Question:
Compliance (in relation to trials)
Answer:
Adherence to all the trialrelated requirements, Good Clinical Practice (GCP) requirements, and the
applicable regulatory requirements.
Question:
Direct Access
Answer:
Permission to examine, analyze, verify, and reproduce any records and reports that are important to
evaluation of a clinical trial.
, Question:
Documentation
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.
Question:
Essential Documents
Answer:
Documents which individually and collectively permit evaluation of the conduct of a study and the
quality of the data produced.
Question:
Good Clinical Practice (GCP)
Answer:
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Question:
Impartial Witness
Answer:
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 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.
Question:
Informed Consent
Answer:
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 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.
update 2026/2027
Question:
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
Question:
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)
Question:
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).
Question:
Audit Trail
Answer:
Documentation that allows reconstruction of the course of events.
Question:
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)
,Question:
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.
Question:
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.
Question:
Clinical Trial/Study Report
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)
Question:
Comparator (Product)
Answer:
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a
clinical trial.
Question:
Compliance (in relation to trials)
Answer:
Adherence to all the trialrelated requirements, Good Clinical Practice (GCP) requirements, and the
applicable regulatory requirements.
Question:
Direct Access
Answer:
Permission to examine, analyze, verify, and reproduce any records and reports that are important to
evaluation of a clinical trial.
, Question:
Documentation
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.
Question:
Essential Documents
Answer:
Documents which individually and collectively permit evaluation of the conduct of a study and the
quality of the data produced.
Question:
Good Clinical Practice (GCP)
Answer:
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Question:
Impartial Witness
Answer:
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 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.
Question:
Informed Consent
Answer:
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 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.
