SRO CERTIFICATION TEST 3 2026 REVIEW
PAPER COMPLETE QUESTIONS WITH EXPERT
SOLUTIONS AND MARKING SCHEME
◉ 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)
PAPER COMPLETE QUESTIONS WITH EXPERT
SOLUTIONS AND MARKING SCHEME
◉ 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)
