ICH GCP for CCRC Exam Prep questions with answers,

ICH GCP for CCRC Exam Prep
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questions with answers /| /|




Adverse Drug Reaction (ADR) - CORRECT ANSWERS ✔✔All noxious
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and unintended responses to a medicinal product related to any
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dose


E6(R1) 1 - CORRECT ANSWERS ✔✔Glossary of terms
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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--any
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unfavorable and unintended sign , symptom, or disease /| /| /| /| /| /| /| /|



temporally associated with the use of a medicinal product,
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whether or not related to the medicinal product
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Applicable Regulatory Requirements - CORRECT ANSWERS ✔✔Any
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law(s) and regulation(s) addressing the conduct of clinical trials of
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investigational products /|




Institutional Review Board Approval - CORRECT ANSWERS ✔✔The
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affirmative decision of the IRB that the clinical trial has been
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reviewed and may be conducted at the institution site within the
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constraints set forth by the IRB, the institution, Good Clinical
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Practice (GCP), and the applicable regulatory requirements
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,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 conducted, and
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the data were recorded, analyzed and accurately reported
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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 Certificate - CORRECT ANSWERS ✔✔A declaration of
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confirmation by the auditor that an audit has taken place /| /| /| /| /| /| /| /| /|




Audit Report - CORRECT ANSWERS ✔✔A written evaluation by the
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sponsor's auditor of the results of the audit
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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 treatment
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assignment(s).


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.
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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
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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 analyses are
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fully integrated into a single report
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Comparator (Product) - CORRECT ANSWERS ✔✔An investigational /| /| /| /| /| /| /|



or marketed product, or placebo, used as a reference in a clinical
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trial.


Compliance to Trials - CORRECT ANSWERS ✔✔Adherence to all the
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trial-related requirements, Good Clinical Practice (GCP) /| /| /| /| /| /|



requirements, and the applicable regulatory requirements /| /| /| /| /|




Confidentiality - CORRECT ANSWERS ✔✔Prevention of disclosure, /| /| /| /| /| /| /|



to other than authorized individuals, of a sponsor's proprietary
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information or of a subject's identity. /| /| /| /| /|




Contract - CORRECT ANSWERS ✔✔A written, dated, and signed
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agreement between two or more involved parties that sets out any
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arrangements on delegation and distribution of tasks and
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obligations and, if appropriate, on financial matters.
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, Coordinating Committee - CORRECT ANSWERS ✔✔A committee /| /| /| /| /| /| /|



that a sponsor may organize to coordinate the conduct of a
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multicenter trial. /|




Coordinating Ivestigator - CORRECT ANSWERS ✔✔An investigator /| /| /| /| /| /| /|



assigned the responsibility for the coordination of investigators at
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different centers participating in a multicenter trial
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Contract Research Organization (CRO) - CORRECT ANSWERS ✔✔A
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person or an organization (commercial, academic, or other)
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contracted by the sponsor to perform one or more of a sponsor's
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trial-related duties and functions. /| /| /|




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 /| /| /| /| /| /| /| /| /|



that describe or record the methods, conduct, and/or results of a
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trial, 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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