SOCRA CERTIFICATION EXAM 2025 WITH
ACCURATE SOLUTIONS- GRADED A+
Exam
Biometrics CORRECT ANSWERA 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 ANSWERAn 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 ANSWERAn 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 ANSWERAny 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 ANSWERA 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 ANSWERAn 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
- Subject to requirements for prior submission or is not subject to requirements for prior submission to
the FDA under the Act
- Results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an
application for a research or marketing permit.
,(21 CFR, sec. 50.3)
Investigator CORRECT ANSWERAn 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 ANSWERA 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 ANSWERAn 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 ANSWERThe scripted name or legal mark of an individual handwritten
by that individual. (21 CFR, Sec. 11.3)
Human Subject CORRECT ANSWERAn 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 ANSWERAny 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 ANSWERAny 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 ANSWERAny 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 ANSWERMeans 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 ANSWERAn 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 ANSWERAny 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 ANSWERA child's affirmative agreement to participate in a clinical investigation. (21
CFR, sec. 50.3)
Children CORRECT ANSWERPersons who have not attained the legal age for consent to treatment or
procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the
clinical investigation will be conducted. (21 CFR, sec. 50.3)
Parent CORRECT ANSWERA child's biological or adoptive parent. (21 CFR, sec. 50.3)
Ward CORRECT ANSWERA child who is placed in legal custody of the State or other agency, institution,
or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3)
Permission CORRECT ANSWERThe agreement of the parent(s) or guardian to the participation of their
child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart
B and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
, Guardian CORRECT ANSWERAn individual who is authorized under applicable State or local law to
consent on behalf of a child to general medical care when general medical care includes research. (21
CFR, sec. 50.3)
Emergency Use CORRECT ANSWERThe use of a test article on a human subject in a life-threatening
situation in which no standard acceptable treatment is available, and in which there is not sufficient
time to obtain IRB approval. (21 CFR, sec. 56.102)
IRB Approval CORRECT ANSWERThe determination of the IRB that the clinical investigation has been
reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other
institutional and federal Requirements. (21 CFR, sec. 56.102)
Contract Research Organization CORRECT ANSWERA person that assumes, as an independent contractor
with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or
monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the
FDA. (21 CFR, sec. 312.3)
IND (also called IDE exemption) CORRECT ANSWER- An investigational new drug application.
- Permits a device that otherwise would be required to comply w/ a performance standard or to have
premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
(21 CFR, sec. 312.3)
Independent Ethics Committee (IEC) CORRECT ANSWERA review panel that is responsible for ensuring
the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation
and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR,
sec. 312.3)
Custom Device CORRECT ANSWERA device that 1) necessarily deviates from devices generally available
2) is not generally available to Physicians/dentists 3) not generally available in finished form for
purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is
intended for use by an individual patient named in the order of the physician or dentist and is made to
be in a specific form for that patient. (21 CFR, sec. 812.3)
ACCURATE SOLUTIONS- GRADED A+
Exam
Biometrics CORRECT ANSWERA 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 ANSWERAn 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 ANSWERAn 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 ANSWERAny 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 ANSWERA 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 ANSWERAn 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
- Subject to requirements for prior submission or is not subject to requirements for prior submission to
the FDA under the Act
- Results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an
application for a research or marketing permit.
,(21 CFR, sec. 50.3)
Investigator CORRECT ANSWERAn 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 ANSWERA 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 ANSWERAn 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 ANSWERThe scripted name or legal mark of an individual handwritten
by that individual. (21 CFR, Sec. 11.3)
Human Subject CORRECT ANSWERAn 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 ANSWERAny 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 ANSWERAny 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 ANSWERAny 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 ANSWERMeans 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 ANSWERAn 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 ANSWERAny 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 ANSWERA child's affirmative agreement to participate in a clinical investigation. (21
CFR, sec. 50.3)
Children CORRECT ANSWERPersons who have not attained the legal age for consent to treatment or
procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the
clinical investigation will be conducted. (21 CFR, sec. 50.3)
Parent CORRECT ANSWERA child's biological or adoptive parent. (21 CFR, sec. 50.3)
Ward CORRECT ANSWERA child who is placed in legal custody of the State or other agency, institution,
or entity, consistent with applicable Federal, State or Local law. (21 CFR, sec. 50.3)
Permission CORRECT ANSWERThe agreement of the parent(s) or guardian to the participation of their
child or ward in a clinical investigation. Permission must be obtained in compliance with part 50 subpart
B and must include all the elements of the informed consent. (21 CFR, sec. 50.3)
, Guardian CORRECT ANSWERAn individual who is authorized under applicable State or local law to
consent on behalf of a child to general medical care when general medical care includes research. (21
CFR, sec. 50.3)
Emergency Use CORRECT ANSWERThe use of a test article on a human subject in a life-threatening
situation in which no standard acceptable treatment is available, and in which there is not sufficient
time to obtain IRB approval. (21 CFR, sec. 56.102)
IRB Approval CORRECT ANSWERThe determination of the IRB that the clinical investigation has been
reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other
institutional and federal Requirements. (21 CFR, sec. 56.102)
Contract Research Organization CORRECT ANSWERA person that assumes, as an independent contractor
with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or
monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the
FDA. (21 CFR, sec. 312.3)
IND (also called IDE exemption) CORRECT ANSWER- An investigational new drug application.
- Permits a device that otherwise would be required to comply w/ a performance standard or to have
premarket approval to be shipped lawfully for the purpose of conducting investigations of that device
(21 CFR, sec. 312.3)
Independent Ethics Committee (IEC) CORRECT ANSWERA review panel that is responsible for ensuring
the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation
and is adequately constituted to provide assurance of that protection. An IRB is one type of IEC. (21 CFR,
sec. 312.3)
Custom Device CORRECT ANSWERA device that 1) necessarily deviates from devices generally available
2) is not generally available to Physicians/dentists 3) not generally available in finished form for
purchase or dispensing 4) is not offered for commercial distribution through labeling/advertising 5) is
intended for use by an individual patient named in the order of the physician or dentist and is made to
be in a specific form for that patient. (21 CFR, sec. 812.3)
