SoCRA Certification Exam 2023
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
