ACRP CCRC CERTIFICATION
PRACTICE SOLUTION PACK 2026
COMPLETE TESTED QUESTIONS
AND CORRECT 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.
◉ Applicable Regulatory Requirement(s). Answer: Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational
products.
◉ Approval (in relation to Institutional Review Boards). Answer: The
affirmative decision of the IRB that the clinical trial has been reviewed
and may 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.
◉ 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 Certificate. Answer: A declaration of confirmation by the
auditor that an audit has taken place.
◉ Audit Report. Answer: A written evaluation by the sponsor's auditor
of the results of the audit.
◉ 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(s).
◉ Single-blinding. Answer: usually refers to the subject(s) being
unaware
◉ Double- blinding. Answer: usually refers to the subject(s),
investigator(s), monitor, and, in some cases, data analyst(s) being
unaware of the treatment assignment(s).
◉ 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.
PRACTICE SOLUTION PACK 2026
COMPLETE TESTED QUESTIONS
AND CORRECT 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.
◉ Applicable Regulatory Requirement(s). Answer: Any law(s) and
regulation(s) addressing the conduct of clinical trials of investigational
products.
◉ Approval (in relation to Institutional Review Boards). Answer: The
affirmative decision of the IRB that the clinical trial has been reviewed
and may 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.
◉ 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 Certificate. Answer: A declaration of confirmation by the
auditor that an audit has taken place.
◉ Audit Report. Answer: A written evaluation by the sponsor's auditor
of the results of the audit.
◉ 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(s).
◉ Single-blinding. Answer: usually refers to the subject(s) being
unaware
◉ Double- blinding. Answer: usually refers to the subject(s),
investigator(s), monitor, and, in some cases, data analyst(s) being
unaware of the treatment assignment(s).
◉ 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.
