Exam (elaborations)
SOCRA CERTIFICATION EXAM QUESTIONS AND VERIFIED ANSWERS (LATEST UPDATE 2024/2025)
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QUESTIONS AND ANSWERS
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SOCRA CERTIFICATION EXAMQUESTIONS AND VERIFIED
ANSWERS (LATEST UPDATE
2024/2025)
Biometrics
A method of verifying an individual's iden7ty based on measurement of the
individual's physical features or repeatable ac7ons where those features and or
ac7ons are both unique to that individual and measurable. (21 CFR, Sec. 11.3)
Closed System
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
An electronic signature based upon cryptographic methods of originator
authen7ca7on, computed by using a set of rules and a set of parameters such
that the iden7ty of the signer and the integrity of the data can be verified. (21
CFR, Sec. 11.3)
Electronic Record
Any combina7on of text, graphics, data, audio, pictorial, or other informa7on
representa7on in digital form that is created, modified, maintained, archived,
retrieved or distributed by a computer system. (21 CFR, Sec. 11.3)
Electronic Signature
A computer data compila7on of any symbol or series of symbols executed,
adopted, or authorized by an individual to be legally binding equivalent of the
handwriLen signature. (21 CFR, Sec. 11.3)
,Open system
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 Inves7ga7on
Any experiment that involves a test ar7cle and one or more human subjects
and that either is subject to requirements for prior submission to the Food and
Drug Administra7on under sec7on 505(i) or 520(g) of the act, or is not subject
to requirements for prior submission to the Food and Drug Administra7on
under these sec7ons of the Act, but the results of which are intended to be
submiLed later to, or held for inspec7on by, the Food and Drug Administra7on
as part of an applica7on for a research or marke7ng permit. (21 CFR, sec. 50.3)
Inves7gator
An individual who actually conducts a clinical inves7ga7on, i.e., under whose
immediate direc7on the test ar7cle is administered or dispensed to, or used
involving, a subject, or, in the event of an inves7ga7on conducted by a team of
individuals, is the responsible leader of that team. (21 CFR, sec. 50.3)
Sponsor
A person who ini7ates a clinical inves7ga7on but who does not actually
conduct the inves7ga7on, i.e., the test ar7cle is administered or dispensed to,
or used involving, a subject under the immediate direc7on of another
individual. A person other than the individual (e.g., corpora7on or agency) that
uses one or more of its own employees to conduct a clinical inves7ga7on it has
ini7ated it has ini7ated is considered to be a sponsor (not a sponsor-
inves7gator), and the employees are considered to be inves7gators. (21 CFR,
sec. 50.3)
Sponsor-Inves7gator
, An individual who both ini7ates and actually conducts, alone or with others, a
clinical inves7ga7on, i.e., under whose immediate direc7on the test ar7cle is
administered or dispensed to, or used involving, a subject. The term does not
include any other person other than an individual, e.g. Corpora7on or agency.
(21 CFR, sec. 50.3)
HandwriLen Signature
The scripted name or legal mark of an individual handwriLen by that
individual. (21 CFR, Sec. 11.3)
Act
The Food, Drug and Cosme7c Act, as amended.
Human Subject
An individual who is or becomes a par7cipant in research, either as a recipient
of the test ar7cle or as a control. A subject may be either a healthy human or a
pa7ent. (21 CFR, sec. 50.3)
Ins7tu7on
Any public or private en7ty or agency (including Federal, State or other
agencies). The word facility as used in sec7on 520(g) of the Act is deemed to by
synonymous with the term ins7tu7on for purposes of this part.(21 CFR, sec.
50.3)
Ins7tu7onal Review Board (IRB)
Any board, commiLee, or other group formally designated by an ins7tu7on to
review biomedical research involving humans as subjects, to approve the
ini7a7on of and conduct periodic review of such research. The term has the
same meaning as the phrase ins7tu7onal review commiLee as used in sec7on
520(g) of the act. (21 CFR, sec. 50.3)
Test Ar7cle
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