SoCRA Certification
ACTUAL Exam LATEST
2025-2026 WITH
QUESTIONS AND
CORRECT VERIFIED
ANSWERS GRADED A+
GUARANTEED 100%
PASS
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)
ACTUAL Exam LATEST
2025-2026 WITH
QUESTIONS AND
CORRECT VERIFIED
ANSWERS GRADED A+
GUARANTEED 100%
PASS
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)
