SOCRA Certification Exam questions and
answers 2025\2026 A+ Grade
Biometrics
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct answer The scripted name or legal mark of an individual handwritten by that individual. (21
CFR, Sec. 11.3)
Act
- correct answer The Food, Drug and Cosmetic Act, as amended.
Human Subject
- correct 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
- correct 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)
- correct 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
- correct 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
- correct 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
- correct 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)
Family Member
- correct answer Any one of the following legally competent persons: spouse; parents; children
(including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual
related by blood or affinity whose close association with the subject is equivalent of a family
relationship. (21 CFR, sec. 50.3)
Assent
- correct answer A child's affirmative agreement to participate in a clinical investigation. Mere failure to
object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
answers 2025\2026 A+ Grade
Biometrics
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct 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
- correct answer The scripted name or legal mark of an individual handwritten by that individual. (21
CFR, Sec. 11.3)
Act
- correct answer The Food, Drug and Cosmetic Act, as amended.
Human Subject
- correct 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
- correct 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)
- correct 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
- correct 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
- correct 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
- correct 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)
Family Member
- correct answer Any one of the following legally competent persons: spouse; parents; children
(including adopted children); brothers, sisters and spouses of brothers and sisters; and any individual
related by blood or affinity whose close association with the subject is equivalent of a family
relationship. (21 CFR, sec. 50.3)
Assent
- correct answer A child's affirmative agreement to participate in a clinical investigation. Mere failure to
object may not, absent affirmative agreement, be construed as assent. (21 CFR, sec. 50.3)
