ACRP CP EXAM SCRIPT 2026 QUESTIONS
WITH ANSWERS GRADED A+
●● 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.
●● 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)
●● Comparator (Product). 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). Answer: Adherence to all the trial-
related requirements, Good Clinical Practice (GCP) requirements, and
the applicable regulatory requirements.
, ●● Direct Access. Answer: Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a
clinical trial.
●● 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.
●● Essential Documents. Answer: Documents which individually and
collectively permit evaluation of the conduct of a study and the quality
of the data produced.
●● 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.
●● 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.
WITH ANSWERS GRADED A+
●● 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.
●● 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)
●● Comparator (Product). 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). Answer: Adherence to all the trial-
related requirements, Good Clinical Practice (GCP) requirements, and
the applicable regulatory requirements.
, ●● Direct Access. Answer: Permission to examine, analyze, verify, and
reproduce any records and reports that are important to evaluation of a
clinical trial.
●● 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.
●● Essential Documents. Answer: Documents which individually and
collectively permit evaluation of the conduct of a study and the quality
of the data produced.
●● 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.
●● 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.
