ACRP CCRC Final EXAM PREP | Questions with
100% Correct Answers | Verified | Latest Update
2026/2027
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Terms in this set (65)
Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new
medicinal product or its new usages, particularly as
the therapeutic dose(s) may not be established: all
noxious and unintended responses to a medicinal
product related to any dose should be considered
adverse drug reactions.
Adverse Event (AE) 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 Any law(s) and regulation(s) addressing the
Requirement(s) conduct of clinical trials of investigational products.
Approval (in relation to Institutional The affirmative decision of the IRB that the clinical
Review Boards) 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 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 A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report A written evaluation by the sponsor's auditor of the
results of the audit.
Audit Trail Documentation that allows reconstruction of the
course of events.
Blinding/Masking A procedure in which one or more parties to the
trial are kept unaware of the treatment
assignment(s).
Single-blinding usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) 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.
100% Correct Answers | Verified | Latest Update
2026/2027
Save
Terms in this set (65)
Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new
medicinal product or its new usages, particularly as
the therapeutic dose(s) may not be established: all
noxious and unintended responses to a medicinal
product related to any dose should be considered
adverse drug reactions.
Adverse Event (AE) 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 Any law(s) and regulation(s) addressing the
Requirement(s) conduct of clinical trials of investigational products.
Approval (in relation to Institutional The affirmative decision of the IRB that the clinical
Review Boards) 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 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 A declaration of confirmation by the auditor that an
audit has taken place.
Audit Report A written evaluation by the sponsor's auditor of the
results of the audit.
Audit Trail Documentation that allows reconstruction of the
course of events.
Blinding/Masking A procedure in which one or more parties to the
trial are kept unaware of the treatment
assignment(s).
Single-blinding usually refers to the subject(s) being unaware
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).
Case Report Form (CRF) 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.
