SoCRA CERTIFICATION EXAM AND PRACTICE
EXAM 2023-2024 ACTUAL EXAMS 100
QUESTIONS AND CORRECT DETAILED ANSWERS
WITH RATIONALES
Terms in this set (138)
A method of verifying an individual's identity based on
measurement of the individual's physical features or
Biometrics repeatable actions where those features and or actions
are both unique to that individual and measurable. (21
CFR, Sec. 11.3)
An environment in which system access is controlled by
persons who are responsible for the content of
Closed System
electronic records that are on the system. (21 CFR, Sec.
11.3)
An electronic signature based upon cryptographic
methods of originator authentication, computed by
Digital Signature using a set of rules and a set of parameters such that the
identity of the signer and the integrity of the data can be
verified. (21 CFR, Sec. 11.3)
Any combination of text, graphics, data, audio, pictorial,
or other information representation in digital form that is
Electronic Record
created, modified, maintained, archived, retrieved or
distributed by a computer system. (21 CFR, Sec. 11.3)
A computer data compilation of any symbol or series of
symbols executed, adopted, or authorized by an
Electronic Signature
individual to be legally binding equivalent of the
handwritten signature. (21 CFR, Sec. 11.3)
, An environment in which system access is not controlled
by persons who are responsible for the content of the
Open system
electronic records that are on the system. (21 CFR, Sec.
11.3)
Any experiment that involves a test article and one or
more human subjects and that either is subject to
requirements for prior submission to the Food and Drug
Administration under section 505(i) or 520(g) of the act,
or is not subject to requirements for prior submission to
Clinical Investigation
the Food and Drug Administration under these sections
of the Act, but the results of which are intended to be
submitted later to, or held for inspection by, the Food
and Drug Administration as part of an application for a
research or marketing permit. (21 CFR, sec. 50.3)
An individual who actually conducts a clinical
investigation, i.e., under whose immediate direction the
test article is administered or dispensed to, or used
Investigator
involving, a subject, or, in the event of an investigation
conducted by a team of individuals, is the responsible
leader of that team. (21 CFR, sec. 50.3)
A person who initiates a clinical investigation but who
does not actually conduct the investigation, i.e., the test
article is administered or dispensed to, or used involving,
a subject under the immediate direction of another
individual. A person other than the individual (e.g.,
Sponsor
corporation or agency) that uses one or more of its own
employees to conduct a clinical investigation it has
initiated it has initiated is considered to be a sponsor
(not a sponsor-investigator), and the employees are
considered to be investigators. (21 CFR, sec. 50.3)
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