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SoCRA Certification Exam Question And Answers 2024
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SoCRA Certification Exam Question AndAnswers 2024
Biometrics - correct answers✅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)
Closed System - correct answers✅An environment in
which system access is controlled by persons who are
responsible for the content of electronic records that are
on the system. (21 CFR, Sec. 11.3)
Digital Signature - correct answers✅An electronic
signature based upon cryptographic methods of
originator authentication, computed by 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)
Electronic Record - correct answers✅Any combination
of text, graphics, data, audio, pictorial, or other
information representation in digital form that is created,
modified, maintained, archived, retrieved or distributed
by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature - correct answers✅A computer
data compilation of any symbol or series of symbols
executed, adopted, or authorized by an individual to be
,SoCRA Certification Exam Question And
Answers 2024
legally binding equivalent of the handwritten signature.
(21 CFR, Sec. 11.3)
Open system - correct answers✅An environment in
which system access is not controlled by persons who are
responsible for the content of the electronic records that
are on the system. (21 CFR, Sec. 11.3)
Clinical Investigation - correct answers✅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 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)
Investigator - correct answers✅An individual who
actually conducts a clinical investigation, i.e., under
whose immediate direction the test article is
administered or dispensed to, or used 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)
, SoCRA Certification Exam Question And
Answers 2024
Sponsor - correct answers✅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., 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)
Sponsor-Investigator - correct answers✅An individual
who both initiates and actually conducts, alone or with
others, a clinical investigation, i.e., under whose
immediate direction the test article is administered or
dispensed to, or used involving, a subject. The term does
not include any other person other than an individual,
e.g. corporation or agency. (21 CFR, sec. 50.3)
Handwritten Signature - correct answers✅The scripted
name or legal mark of an individual handwritten by that
individual. (21 CFR, Sec. 11.3)
Act - correct answers✅The Food, Drug and Cosmetic
Act, as amended.
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