SOCRA CERTIFICATION UPDATED EXAM SCRIPT
QUESTIONS AND SOLUTIONS RATED A+
✔✔Institution - ✔✔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)
✔✔Institutional Review Board (IRB) - ✔✔Any 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 - ✔✔Any 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 - ✔✔Means 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 - ✔✔An 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 - ✔✔Any 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 - ✔✔A child's affirmative agreement to participate in a clinical investigation.
Mere failure to object may not, absent affirmative agreement, be construed as assent.
(21 CFR, sec. 50.3)
✔✔Children - ✔✔Persons 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 - ✔✔A child's biological or adoptive parent. (21 CFR, sec. 50.3)
✔✔Ward - ✔✔A 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 - ✔✔The 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 - ✔✔An 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 - ✔✔The 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 no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102)
✔✔IRB Approval - ✔✔The 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 - ✔✔A 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 - ✔✔An investigational new drug application. Is synonymous with "Notice of
Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3)
✔✔Independent Ethics Committee (IEC) - ✔✔A review panel the 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 - ✔✔A 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)
✔✔Implant - ✔✔A device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or more. (21 CFR,
sec. 812.3)
✔✔Investigational Device - ✔✔A device, including a transitional device that is the object
of investigation. (21 CFR, sec. 812.3)
QUESTIONS AND SOLUTIONS RATED A+
✔✔Institution - ✔✔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)
✔✔Institutional Review Board (IRB) - ✔✔Any 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 - ✔✔Any 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 - ✔✔Means 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 - ✔✔An 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 - ✔✔Any 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 - ✔✔A child's affirmative agreement to participate in a clinical investigation.
Mere failure to object may not, absent affirmative agreement, be construed as assent.
(21 CFR, sec. 50.3)
✔✔Children - ✔✔Persons 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 - ✔✔A child's biological or adoptive parent. (21 CFR, sec. 50.3)
✔✔Ward - ✔✔A 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 - ✔✔The 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 - ✔✔An 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 - ✔✔The 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 no sufficient time to obtain IRB approval. (21 CFR, sec. 56.102)
✔✔IRB Approval - ✔✔The 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 - ✔✔A 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 - ✔✔An investigational new drug application. Is synonymous with "Notice of
Claimed Investigational Exemption for a New Drug". (21 CFR, sec. 312.3)
✔✔Independent Ethics Committee (IEC) - ✔✔A review panel the 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 - ✔✔A 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)
✔✔Implant - ✔✔A device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or more. (21 CFR,
sec. 812.3)
✔✔Investigational Device - ✔✔A device, including a transitional device that is the object
of investigation. (21 CFR, sec. 812.3)
