CCRC ACRP Review Set Exam Questions
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Latest Updated 2026
Good Clinical Practice: E6(R2)
Integrated addendum to ICH
E6(R1)
Glossary E6 Section 1
Any untoward medical E6 1.2 Adverse Event (AE)
occurrence in a patient or
clinical investigation subject
administered a pharmaceutical
product and which does not
necessarily have a causal
relationship with this
treatment
See Protocol Amendment. E6 1.3 Amendment (to the protocol)
Any law(s) and regulation(s) E6 Applicable Regulatory
addressing the conduct of Requriement(s)
clinical trials of investigational
products.
The affirmative decision of the E6 1.5 Approval (in relation to
IRB that the clinical trial has institutional review boards (IRBs))
been reviewed and ma be
conducted at the institution
site within the constraints set
,forth by the IRB, the
institution, good clinical
practice (GCP), and the
applicable regulatory
requirements.
A systematic and independent E6 1.6 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 E6 1.7 Audit Certificate
by the auditor that an audit
has taken place.
A written evaluation by the E6 1.8 Audit Report
sponsor's auditor of the results
of the audit.
Documentation that allows E6 1.9 Audit Trail
reconstruction of the course of
events.
, A procedure in which one or E6 1.10 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,
insome cases, data analyst(s)
being unaware of the
treatment assignment(s).
A printed, optical, or electronic E6 1.11 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 E6 1.12 Clinical Trial/Study
subjects intended to discover
or verify the clincal,
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
and Answers with Verified Solutions |
Latest Updated 2026
Good Clinical Practice: E6(R2)
Integrated addendum to ICH
E6(R1)
Glossary E6 Section 1
Any untoward medical E6 1.2 Adverse Event (AE)
occurrence in a patient or
clinical investigation subject
administered a pharmaceutical
product and which does not
necessarily have a causal
relationship with this
treatment
See Protocol Amendment. E6 1.3 Amendment (to the protocol)
Any law(s) and regulation(s) E6 Applicable Regulatory
addressing the conduct of Requriement(s)
clinical trials of investigational
products.
The affirmative decision of the E6 1.5 Approval (in relation to
IRB that the clinical trial has institutional review boards (IRBs))
been reviewed and ma be
conducted at the institution
site within the constraints set
,forth by the IRB, the
institution, good clinical
practice (GCP), and the
applicable regulatory
requirements.
A systematic and independent E6 1.6 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 E6 1.7 Audit Certificate
by the auditor that an audit
has taken place.
A written evaluation by the E6 1.8 Audit Report
sponsor's auditor of the results
of the audit.
Documentation that allows E6 1.9 Audit Trail
reconstruction of the course of
events.
, A procedure in which one or E6 1.10 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,
insome cases, data analyst(s)
being unaware of the
treatment assignment(s).
A printed, optical, or electronic E6 1.11 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 E6 1.12 Clinical Trial/Study
subjects intended to discover
or verify the clincal,
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
