DEFINITIONS AND IMPORTANT TERMS
(ACRP- CP) Exam Questions and Answers
with Verified Solutions | Latest Updated
2026
All noxious and unintended Adverse Drug Reaction (ADR)
responses to a medicinal
product related to any dose,
particularly in pre-approval
clinical experience.
Any untoward medical Adverse Event (AE)
occurrence in a patient or
clinical investigation subject
administered a pharmaceutical
product, which does not
necessarily have a causal
relationship with the
treatment.
Any law(s) and regulation(s) Applicable Regulatory
addressing the conduct of Requirement(s)
clinical trials of investigational
products.
A systematic and independent Audit
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).
A declaration of confirmation Audit Certificate
by the auditor that an audit
has taken place.
A written evaluation by the Audit Report
sponsor's auditor of the results
of the audit.
Documentation that allows Audit Trail
reconstruction of the course of
events.
A procedure in which one or Blinding/Masking
more parties to the trial are
kept unaware of the treatment
assignment(s). 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).
, A printed, optical, or electronic Case Report Form (CRF)
document designed to record
all of the protocol required
information to be reported to
the sponsor on each trial
subject.
Any investigation in human Clinical Trial/Study
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. The
terms clinical trial and clinical
study are synonymous.
An investigational or marketed Comparator (Product)
product (i.e., active control), or
placebo, used as a reference
in a clinical trial.
Adherence to all the Compliance (in relation to trials)
trial-related requirements,
Good Clinical Practice (GCP)
requirements, and the
applicable regulatory
(ACRP- CP) Exam Questions and Answers
with Verified Solutions | Latest Updated
2026
All noxious and unintended Adverse Drug Reaction (ADR)
responses to a medicinal
product related to any dose,
particularly in pre-approval
clinical experience.
Any untoward medical Adverse Event (AE)
occurrence in a patient or
clinical investigation subject
administered a pharmaceutical
product, which does not
necessarily have a causal
relationship with the
treatment.
Any law(s) and regulation(s) Applicable Regulatory
addressing the conduct of Requirement(s)
clinical trials of investigational
products.
A systematic and independent Audit
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).
A declaration of confirmation Audit Certificate
by the auditor that an audit
has taken place.
A written evaluation by the Audit Report
sponsor's auditor of the results
of the audit.
Documentation that allows Audit Trail
reconstruction of the course of
events.
A procedure in which one or Blinding/Masking
more parties to the trial are
kept unaware of the treatment
assignment(s). 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).
, A printed, optical, or electronic Case Report Form (CRF)
document designed to record
all of the protocol required
information to be reported to
the sponsor on each trial
subject.
Any investigation in human Clinical Trial/Study
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. The
terms clinical trial and clinical
study are synonymous.
An investigational or marketed Comparator (Product)
product (i.e., active control), or
placebo, used as a reference
in a clinical trial.
Adherence to all the Compliance (in relation to trials)
trial-related requirements,
Good Clinical Practice (GCP)
requirements, and the
applicable regulatory
