SoCRA Certification Exam Practice Latest 2026 Updated
Questions and Verified 100% Solutions (2026/2027) Grade:
A+|Status: Guaranteed Pass
Act - Answers -The Food, Drug and Cosmetic Act, as amended.
Human Subject - Answers -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 - Answers -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) - Answers -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 - Answers -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)
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,Minimal Risk - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -A child's biological or adoptive parent. (21 CFR, sec. 50.3)
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, Ward - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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)
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Questions and Verified 100% Solutions (2026/2027) Grade:
A+|Status: Guaranteed Pass
Act - Answers -The Food, Drug and Cosmetic Act, as amended.
Human Subject - Answers -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 - Answers -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) - Answers -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 - Answers -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)
1|Page
,Minimal Risk - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -A child's biological or adoptive parent. (21 CFR, sec. 50.3)
2|Page
, Ward - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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)
3|Page
