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ACRP CCRC EXAM PREP|135 QUESTIONS AND ANSWERS
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ACRP CCRC EXAM PREP|135 QUESTIONS AND ANSWERS
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ACRP CCRC EXAM PREP|135 QUESTIONSAND ANSWERS
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 Requirement(s) - -Any law(s) and regulation(s)
addressing the conduct of clinical trials of investigational products.
-Approval (in relation to Institutional Review Boards) - -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 - -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.
-Clinical Trial/Study - -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 - -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) - -An investigational or marketed product (i.e., active
control), or placebo, used as a reference in a clinical trial.
-Compliance (in relation to trials) - -Adherence to all the trial-related
requirements, Good Clinical Practice (GCP) requirements, and the applicable
regulatory requirements.
-Confidentiality - -Prevention of disclosure, to other than authorized
individuals, of a sponsor's proprietary information or of a subject's identity.
-Contract - -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 - -A committee that a sponsor may organize to
coordinate the conduct of a multicentre trial.
-Coordinating Investigator - -An investigator assigned the responsibility for
the coordination of investigators at different centres participating in a
multicentre trial.
-Contract Research Organization (CRO) - -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.
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