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ACRP CCRC EXAM Questions and Answers Latest Versions 2024 GRADE A+
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ACRP CCRC EXAM Questions and Answers Latest Versions 2024 GRADE A+
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ACRP CCRC EXAM Questionsand Answers Latest Versions
2024 GRADE A+.
Adverse Drug Reaction (ADR) - 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) - 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.
Clinical Trial/Study - Answer Any investigation in human 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.
Clinical Trial/Study Report - Answer A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which
the clinical and statistical description, presentations, and analyses are fully
integrated into a single report
Comparator (Product) - Answer An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
Compliance (in relation to trials) - Answer Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
Confidentiality - Answer Prevention of disclosure, to other than authorized
individuals, of a sponsor's proprietary information or of a subject's identity.
Contract - Answer A written, dated, and signed agreement between two or more
involved parties that sets out any arrangements on delegation and distribution of
tasks and obligations and, if appropriate, on financial matters.
Coordinating Committee - Answer A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial.
Coordinating Investigator - Answer An investigator assigned the responsibility for the
coordination of investigators at different centres participating in a multicentre trial.
Contract Research Organization (CRO) - Answer A person or an organization
(commercial, academic, or other) contracted by the sponsor to perform one or more
of a sponsor's trial-related duties and functions.
Direct Access - Answer Permission to examine, analyze, verify, and reproduce any
records and reports that are important to evaluation of a clinical trial.
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