SOCRA FINAL PAPER COMPLETE
QUESTIONS AND ACCURATE SOLUTIONS
STUDY GUIDE
●● 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
QUESTIONS AND ACCURATE SOLUTIONS
STUDY GUIDE
●● 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
