SOCRA CERTIFICATION CORE MAIN EXAM
QUESTIONS AND ANSWERS SURE A+
✔✔The Code of Federal Regulations that applies to investigational new drug application
is: - ✔✔21 CFR 312
✔✔What does 21 CFR 54 deal with? - ✔✔Financial Disclosure of clinical investigators
✔✔A(n) ____ is an investigation or marked product, or placebo, used as a reference in
a clinical trial. - ✔✔Comparator, Product
✔✔What is the FDA form 3454? - ✔✔Certification - Financial Interests and
Arrangements of Clinical Investigators
✔✔What is a person or an organization (commercial, academic, or other) contracted by
the sponsor of a clinical trial to perform one or more trial-related duty and function? -
✔✔CRO - Contracted Research Organization
✔✔The international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects is known
as - ✔✔Good Clinical Practice (GCP)
✔✔What is 21 CFR 50/51 subpart D? - ✔✔Clinical investigations not involving greater
than minimal risk- children
- Remember that ALL sections under subpart D of 21 CFR 50 deal with children - the
heading for all of subpart D is additional Safeguards for children in clinical Investigations
✔✔What is 21 CFR 50.54 Subpart D? - ✔✔Clinical investigations not otherwise
approvable that presents an opportunity to understand, prevent or alleviate a serious
problem affecting the health or welfare of children.
, ✔✔What is 21 CFR50 subpart D? - ✔✔Additional Safeguards for Children in Clinical
Investigations
✔✔The Code of Federal regulations that applies to the Protection of Human Subjects is
- ✔✔45 CFR 46
✔✔What are the three fundamental ethical principals for human subjects research -
✔✔1. respect for persons
2. beneficience
3. justice
✔✔The FDA form 483 is used for: - ✔✔Inspectional Observations
✔✔A(n) ______ can be any unfavorable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of a
medicinal (investigational) product, whether or not related to the medicinal
(investigational) product. - ✔✔Adverse Event, AE
✔✔What is 21 CFR50 subpart B? - ✔✔Protection of Human Subjects
✔✔The IRB may, for some or all subject, waive the requirement hat the subject, or the
subjects legally authorized representative, sign a written consent form if it finds that the
research presents more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside the research context -
✔✔a. true
b. false X
- The IRB may. for some or all subjects, waive the requirement that the subjects or the
subject's legally authorized representative, sign a written consent form if it finds the
research presents NO more than minimal risk. The IRB may not do this for research that
is more than minimal risk.
✔✔Which of the following is 21 CFR 56.106 Subpart B? - ✔✔Registration
✔✔What is 21 CFR50.52 Subpart D? - ✔✔Clinical investigations involving greater than
minimal risk, but presenting the prospect of direct benefit to individual subjects children
✔✔Which of the following are necessary to satisfy 21 CFR 50.24 subpart B? - ✔✔-
Participation in the research holds out the prospect of direct benefit to the subjects - as
described in 21 CFR 50.24 (a)
- Obtaining informed consent not feasible - as described in 21 CFR 50.24 (a)
- The clinical investigation could not practicably be carried out without the waiver.
- The human subjects are in a life-threatening situation, available treatments are
unproven or unsatisfactory, and the collection of valid scientific evidence, which may
QUESTIONS AND ANSWERS SURE A+
✔✔The Code of Federal Regulations that applies to investigational new drug application
is: - ✔✔21 CFR 312
✔✔What does 21 CFR 54 deal with? - ✔✔Financial Disclosure of clinical investigators
✔✔A(n) ____ is an investigation or marked product, or placebo, used as a reference in
a clinical trial. - ✔✔Comparator, Product
✔✔What is the FDA form 3454? - ✔✔Certification - Financial Interests and
Arrangements of Clinical Investigators
✔✔What is a person or an organization (commercial, academic, or other) contracted by
the sponsor of a clinical trial to perform one or more trial-related duty and function? -
✔✔CRO - Contracted Research Organization
✔✔The international ethical and scientific quality standard for designing, conducting,
recording and reporting trials that involve the participation of human subjects is known
as - ✔✔Good Clinical Practice (GCP)
✔✔What is 21 CFR 50/51 subpart D? - ✔✔Clinical investigations not involving greater
than minimal risk- children
- Remember that ALL sections under subpart D of 21 CFR 50 deal with children - the
heading for all of subpart D is additional Safeguards for children in clinical Investigations
✔✔What is 21 CFR 50.54 Subpart D? - ✔✔Clinical investigations not otherwise
approvable that presents an opportunity to understand, prevent or alleviate a serious
problem affecting the health or welfare of children.
, ✔✔What is 21 CFR50 subpart D? - ✔✔Additional Safeguards for Children in Clinical
Investigations
✔✔The Code of Federal regulations that applies to the Protection of Human Subjects is
- ✔✔45 CFR 46
✔✔What are the three fundamental ethical principals for human subjects research -
✔✔1. respect for persons
2. beneficience
3. justice
✔✔The FDA form 483 is used for: - ✔✔Inspectional Observations
✔✔A(n) ______ can be any unfavorable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated with the use of a
medicinal (investigational) product, whether or not related to the medicinal
(investigational) product. - ✔✔Adverse Event, AE
✔✔What is 21 CFR50 subpart B? - ✔✔Protection of Human Subjects
✔✔The IRB may, for some or all subject, waive the requirement hat the subject, or the
subjects legally authorized representative, sign a written consent form if it finds that the
research presents more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside the research context -
✔✔a. true
b. false X
- The IRB may. for some or all subjects, waive the requirement that the subjects or the
subject's legally authorized representative, sign a written consent form if it finds the
research presents NO more than minimal risk. The IRB may not do this for research that
is more than minimal risk.
✔✔Which of the following is 21 CFR 56.106 Subpart B? - ✔✔Registration
✔✔What is 21 CFR50.52 Subpart D? - ✔✔Clinical investigations involving greater than
minimal risk, but presenting the prospect of direct benefit to individual subjects children
✔✔Which of the following are necessary to satisfy 21 CFR 50.24 subpart B? - ✔✔-
Participation in the research holds out the prospect of direct benefit to the subjects - as
described in 21 CFR 50.24 (a)
- Obtaining informed consent not feasible - as described in 21 CFR 50.24 (a)
- The clinical investigation could not practicably be carried out without the waiver.
- The human subjects are in a life-threatening situation, available treatments are
unproven or unsatisfactory, and the collection of valid scientific evidence, which may
