ACRP CCRC EXAM PREP| 135 questions|
WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: In the pre-approval clinical experience with a
new medicinal product or its new usages, particularly as the therap
...
ACRP CCRC EXAM PREP| 135 questions|
WITH COMPLETE SOLUTION
Adverse Drug Reaction (ADR) Correct Answer: 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) Correct 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) Correct Answer: Any law(s) and regulation(s) addressing
the conduct of clinical trials of investigational products.
Approval (in relation to Institutional Review Boards) Correct 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 Correct 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 Correct Answer: A declaration of confirmation by the auditor that an audit has
taken place.
Audit Report Correct Answer: A written evaluation by the sponsor's auditor of the results of the
audit.
Audit Trail Correct Answer: Documentation that allows reconstruction of the course of events.
Blinding/Masking Correct Answer: A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment(s).
Single-blinding Correct Answer: usually refers to the subject(s) being unaware
Double- blinding Correct 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) Correct 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.
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