ACRP-CP Exam Review QUESTIONS WITH ANSWERS

ACRP-CP Exam Review |\ |\ |\




QUESTIONS WITH ANSWERS |\ |\




Adverse Drug Reaction (ADR) - CORRECT ANSWERS ✔✔All
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noxious and unintended responses to a medicinal product related
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to any dose (causal relationship is at least a reasonable
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possibility). Regarding marketed medicinal products: a response
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to a drug which is noxious and unintended and which occurs at
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doses normally used in man for prophylaxis, diagnosis, or therapy
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of diseases or for modification of physiological function
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Adverse Event (AE) - CORRECT ANSWERS ✔✔Any untoward
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medical occurrence in a patient or clinical investigation subject
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administered a pharmaceutical product and which does not |\ |\ |\ |\ |\ |\ |\ |\


necessarily have a causal relationship with this treatment. (ICH
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GCP E6 1.2) |\ |\




Audit - CORRECT ANSWERS ✔✔A systematic and independent
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examination of trial related activities and documents to |\ |\ |\ |\ |\ |\ |\ |\


determine whether the evaluated trial related activities were
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conducted, and the data were recorded, analyzed and accurately
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reported according to the protocol, sponsor's standard operating
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procedures (SOPs), Good Clinical Practice (GCP), and the |\ |\ |\ |\ |\ |\ |\ |\


applicable regulatory requirement(s). |\ |\




Audit Trail - CORRECT ANSWERS ✔✔Documentation that allows
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reconstruction of the course of events. |\ |\ |\ |\ |\

,Blinding/Masking - CORRECT ANSWERS ✔✔A procedure in which |\ |\ |\ |\ |\ |\ |\ |\


one or more parties to the trial are kept unaware of the
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treatment assignment. Single-blinding usually refers to the
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subject(s) being unaware, and double- blinding usually refers to
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the subject(s), investigator(s), monitor, and, in some cases, data
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analyst(s) being unaware of the treatment assignment(s). (ICH
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GCP E6 1.10) |\ |\




Case Report Form (CRF) - CORRECT ANSWERS ✔✔A printed,
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optical, or electronic document designed to record all of the
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protocol required information to be reported to the sponsor on
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each trial subject. |\ |\




Clinical Trial/Study - CORRECT ANSWERS ✔✔Any investigation in
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human subjects intended to discover or verify the clinical,
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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
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absorption, distribution, metabolism, and excretion of an|\ |\ |\ |\ |\ |\ |\


investigational product(s) with the object of ascertaining its |\ |\ |\ |\ |\ |\ |\ |\


safety and/or efficacy. |\ |\




Clinical Trial/Study Report - CORRECT ANSWERS ✔✔A written
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description of a trial/study of any therapeutic, prophylactic or
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diagnostic agent conducted in human subjects, in which the
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clinical and statistical description, presentations, and analysis are
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fully integrated into a single report. (ICH GCP E6 1.13)
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Comparator (Product) - CORRECT ANSWERS ✔✔An investigational |\ |\ |\ |\ |\ |\


or marketed product (i.e., active control), or placebo, used as a
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reference in a clinical trial. |\ |\ |\ |\

, Compliance (in relation to trials) - CORRECT ANSWERS |\ |\ |\ |\ |\ |\ |\ |\


✔✔Adherence to all the trial-related requirements, Good Clinical |\ |\ |\ |\ |\ |\ |\ |\


Practice (GCP) requirements, and the applicable regulatory
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requirements.


Direct Access - CORRECT ANSWERS ✔✔Permission to examine,
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analyze, verify, and reproduce any records and reports that are
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important to evaluation of a clinical trial. |\ |\ |\ |\ |\ |\




Documentation - CORRECT ANSWERS ✔✔All records, in any form |\ |\ |\ |\ |\ |\ |\ |\ |\


(including, but not limited to, written, electronic, magnetic, and
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optical records, and scans, x-rays, and electrocardiograms) that
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describe or record the methods, conduct, and/or results of a trial,
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the factors affecting a trial, and the actions taken.
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Essential Documents - CORRECT ANSWERS ✔✔Documents which
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individually and collectively permit evaluation of the conduct of a
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study and the quality of the data produced.
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Good Clinical Practice (GCP) - CORRECT ANSWERS ✔✔A standard
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for the design, conduct, performance, monitoring, auditing,
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recording, analyses, and reporting of clinical trials that provides
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assurance that the data and reported results are credible and
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accurate, and that the rights, integrity, and confidentiality of trial
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subjects are protected.
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Impartial Witness - CORRECT ANSWERS ✔✔A person, who is
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independent of the trial, who cannot be unfairly influenced by |\ |\ |\ |\ |\ |\ |\ |\ |\ |\


people involved with the trial, who attends the informed consent
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