SoCRA Certification Exam 2026
Questions and Answers
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,
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,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
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, 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.
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Questions and Answers
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,
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
,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
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, 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.
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