SoCRA Certification Exam Questions
and Answers 100% Correct
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)
Closed System - ANSWER -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 - ANSWER -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 - ANSWER -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 - ANSWER -A computer data compilation of any symbol or series
of symbols executed, adopted, or authorized by an individual to be legally binding
equivalent of the handwritten signature. (21 CFR, Sec. 11.3)
Open system - ANSWER -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 - ANSWER -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 - ANSWER -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)
, Sponsor - ANSWER -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 - ANSWER -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 - ANSWER -The scripted name or legal mark of an individual
handwritten by that individual. (21 CFR, Sec. 11.3)
Act - ANSWER -The Food, Drug and Cosmetic Act, as amended.
Human Subject - ANSWER -An individual who is or becomes a participant in research,
either as a recipient of the test article or as a control. A subject may be either a healthy
human or a patient. (21 CFR, sec. 50.3)
Institution - ANSWER -Any public or private entity or agency (including Federal, State or
other agencies). The word facility as used in section 520(g) of the Act is deemed to by
synonymous with the term institution for purposes of this part.(21 CFR, sec. 50.3)
Institutional Review Board (IRB) - ANSWER -Any board, committee, or other group
formally designated by an institution to review biomedical research involving humans as
subjects, to approve the initiation of and conduct periodic review of such research. The
term has the same meaning as the phrase institutional review committee as used in
section 520(g) of the act. (21 CFR, sec. 50.3)
Test Article - ANSWER -Any food or drug (including a biological product for human
use), medical device for human use, human food additive, color additive, electronic
product, or any other article subject to regulation under the act or under sections 351,
and 354-360F of the Public Health Services Act. (21 CFR, sec. 50.3)
Minimal Risk - ANSWER -Means that the probability and magnitude of harm or
discomfort anticipated in the research are no greater in an of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests. (21 CFR, sec. 50.3)
Legally Authorized Representative - ANSWER -An individual or judicial or other body
authorized under applicable law to consent on behalf of a prospective subject to the
subject's participation in the procedures involved. (21 CFR, sec. 50.3)
