SOCRA CERTIFICATION EXAM SCRIPTED UPDATED
QUESTIONS AND ANSWERS SURE A+
✔✔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)
✔✔Monitor - ✔✔When used as a noun, means an individual designated by a sponsor or
contract research organization to oversee the progress of and investigation. When used
as a verb, means to oversee and investigation. (21 CFR, sec. 812.3)
✔✔Noninvasive diagnostic device or procedure - ✔✔One that does NOT 1) penetrate
the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear
beyond the external auditory canal, the nose beyond the nares, the mouth beyond the
pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. (21
CFR, sec. 812.3)
✔✔Significant Risk Device - ✔✔An investigational device that 1) is intended as an
implant and presents a potential for serious risk to the health, safety or welfare of the
subject 2) is purposed or represented to be for a use in supporting or sustaining human
life and presents a potential serious risk 3) is for a use of substantial importance in
diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of
human health. (21 CFR, sec. 812.3)
✔✔Termination - ✔✔A discontinuance, b a sponsor or by withdrawal of IRB or FDA
approval, of an investigation before completion. (21 CFR, sec. 812.3)
✔✔Translational Device - ✔✔A device that FDA considered to be a new drug or and
antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3)
QUESTIONS AND ANSWERS SURE A+
✔✔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)
✔✔Monitor - ✔✔When used as a noun, means an individual designated by a sponsor or
contract research organization to oversee the progress of and investigation. When used
as a verb, means to oversee and investigation. (21 CFR, sec. 812.3)
✔✔Noninvasive diagnostic device or procedure - ✔✔One that does NOT 1) penetrate
the skin or mucous membranes of the body, ocular cavity or the urethra 2) enter the ear
beyond the external auditory canal, the nose beyond the nares, the mouth beyond the
pharynx, the anal canal beyond the rectum or the vagina beyond the cervical os. (21
CFR, sec. 812.3)
✔✔Significant Risk Device - ✔✔An investigational device that 1) is intended as an
implant and presents a potential for serious risk to the health, safety or welfare of the
subject 2) is purposed or represented to be for a use in supporting or sustaining human
life and presents a potential serious risk 3) is for a use of substantial importance in
diagnosing, curing , mitigating or treating disease or otherwise preventing impairment of
human health. (21 CFR, sec. 812.3)
✔✔Termination - ✔✔A discontinuance, b a sponsor or by withdrawal of IRB or FDA
approval, of an investigation before completion. (21 CFR, sec. 812.3)
✔✔Translational Device - ✔✔A device that FDA considered to be a new drug or and
antibiotic drug before May 28, 1976. (21 CFR, sec. 812.3)
