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SoCRA Certification Exam 2024/2025 Graded A+
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SoCRA Certification Exam 2024/2025 Graded A+
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SoCRA Certification Exam 2024/2025Graded A+
21 CFR 11 - ANSWER-Electronic Records/Signatures
21 CFR 312 - ANSWER-IND
21 CFR 50 - ANSWER-Protection of Human Subjets/Informed Consent
21 CFR 56 - ANSWER-IRB
21 CFR 812 - ANSWER-IDE
3 regulatory agency sponsors of ICH - ANSWER-European Union, Japan, United States
45 CFR - ANSWER-The Common Rule
45 CFR Part B - ANSWER-Pregnant Women and Fetuses
45 CFR Part C - ANSWER-Prisoners
45 CFR Part D - ANSWER-Children
45 CFR Part E - ANSWER-IRBs
According to GCP guidelines, does the term vulnerable subject also include employees
under direct supervision of clinical investigator? - ANSWER-Yes
According to ICH guidelines, how many members should an IRB have? - ANSWER-at
least 5
According to ICH guidelines, IRB must retain records for... - ANSWER-3 years
Act - ANSWER-The Food, Drug and Cosmetic Act, as amended.
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a
medicinal product related to any dose. (ICH GCP E6 1.1)
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. (ICH GCP E6 1.2)
Applicable Regulatory Requirements - ANSWER-Any laws and regulations addressing
the conduct of clinical trials of investigational products (ICH GCP E6 1.4)
, Are devices intended solely for veterinary use exempt form IDE regulations? -
ANSWER-Yes
Assent - ANSWER-A child's affirmative agreement to participate in a clinical
investigation. Mere failure to object may not, absent affirmative agreement, be
construed as assent. (21 CFR, sec. 50.3)
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, sponsors SOPs, GCP and the applicable regulatory requirements. (ICH
GCP E6 1.6)
Audit Certificate - ANSWER-A declaration of the confirmation by the auditor that an
audit has taken place. (ICH GCP E6 1.7)
Audit Report - ANSWER-A written evaluation by the sponsor's auditor of the results of
the audit. (ICH GCP E6 1.8)
Audit Trail - ANSWER-Documentation that allow reconstruction of the course of events.
(ICH GCP E6 1.9)
Belmont Report - ANSWER-1979
Biometrics - ANSWER-A method of verifying an individual's identity based on
measurement of the individual's physical features or repeatable actions where those
features and or actions are both unique to that individual and measurable. (21 CFR,
Sec. 11.3)
Blinding/Masking - 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) - 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)
Certification - 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)
Children - ANSWER-Persons who have not attained the legal age for consent to
treatment or procedures involved in clinical investigations, under the applicable law of
the jurisdiction in which the clinical investigation will be conducted. (21 CFR, sec. 50.3)
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