SoCRA CCRP Test Exam Review Questions with all Answers verified for accuracy Updated 2024/2025
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Course
CCRP SOCRA
Institution
CCRP SOCRA
SoCRA CCRP Test Exam Review Questions with all Answers verified for accuracy Updated 2024/2025
Viable - correct answer as it pertains to the neonate, means being able after delivery to survive.
Human Subject - correct answer A living individual about whom an investigator conducting research o...
SoCRA CCRP Test Exam Review Questions
with all Answers verified for accuracy
Updated 2024/2025
Viable - correct answer as it pertains to the neonate, means
being able after delivery to survive.
Human Subject - correct answer A living individual about whom
an investigator conducting research obtains 1)Data through
intervention or interaction with the individual 2) Identifiable
private information. (45 CFR, sec. 46.102)
Certification - correct answer The official notification by the
institution to the supporting department or agency, in
accordance with the requirements of this policy, that a research
project or activity involving human subjects has been reviewed
and approved by an IRB in accordance with an approved
assurance. (45 CFR, sec. 46.102)
Adverse Drug Reaction (ADR) - correct answer All noxious and
unintended responses to a medicinal product related to any dose.
(ICH GCP E6 1.1)
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. (ICH
GCP E6 1.2)
,Applicable Regulatory Requirements - correct answer Any laws
and regulations addressing the conduct of clinical trials of
investigational products (ICH GCP E6 1.4)
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, sponsors SOPs, GCP and the
applicable regulatory requirements. (ICH GCP E6 1.6)
Audit Certificate - correct answer A declaration of the
confirmation by the auditor that an audit has taken place. (ICH
GCP E6 1.7)
Audit Report - correct answer A written evaluation by the
sponsor's auditor of the results of the audit. (ICH GCP E6 1.8)
Audit Trail - correct answer Documentation that allow
reconstruction of the course of events. (ICH GCP E6 1.9)
Blinding/Masking - correct answer A procedure in which one or
more parties to the trial are kept unaware of the treatment
assignment. (ICH GCP E6 1.10)
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. (ICH GCP E6 1.11)
, Clinical Trial/Study Report - correct 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 analysis
are fully integrated into a single report. (ICH GCP E6 1.13)
Comparator (Product) - correct answer An investigational or
marketed product (i.e. active control). or placebo, used as a
reference in a clinical trial. (ICH GCP E6 1.14)
Compliance - correct answer Adherence to all the trial related
requirements, GCP requirements and the applicable regulatory
requirements. (ICH GCP E6 1.15)
Confidentiality - correct answer Prevention or disclosure, to
other than authorized individuals, of a sponsor's proprietary
information or of a subject's identity. (ICH GCP E6 1.16)
Contract - correct 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. (ICH GCP E6
1.17)
Coordinating Committee - correct answer A committee that a
sponsor may organize to coordinate the conduct of a multicentre
trial. (ICH GCP E6 1.18)
Coordinating Investigator - correct answer An investigator
assigned the responsibility for the coordination of investogators
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