February 2024 SOCRA Source Journal - Journal - Page 11
SELF STUDY QUESTIONS
1. To offer a prospect of indirect benefit, any dose planned for use in a pediatric clinical investigation should have the
potential to have a therapeutic effect based on available scientific information.
a. True
b. False
2. Factors to consider when designing a clinical investigation and assessing the potential risks to children involved in the
study include _________.
a. Current severity of the condition to be treated in the child
b. Age and degree of physiological maturity of the child
c. Presence of other complicating family situations
d. All of the above
e. Only a. and b.
3. In the context of a clinical investigation, procedures that are carried out as part of routine clinical care of a child generally
are considered to offer a clinical benefit and do require evaluation as a research intervention under the regulations.
a. True
b. False
4. In March 2015, the Pediatric Ethics Subcommittee of the FDA’s Pediatric Advisory Committee met to discuss the use of
non-therapeutic procedural sedation and came to the following areas of agreement when considering the use of sedation
for a non-therapeutic procedure:
a. Procedures should be performed at a high-volume center with a dedicated pediatric sedation service.
b. The approach to procedural sedation and risk minimization procedures should be institutionally directed.
c. Children with chronic conditions that may place them at higher risk from procedural sedation should be carefully
evaluated and potentially excluded from the protocol.
d. All of above
e. Only a. and c.
5. Large organ biopsies when done for research-related purposes only have generally been considered to exceed a minimal
increase over minor risk, and should not be done in children unless the procedure is performed as part of the routine
clinical care for that child in the treatment of their condition.
a. True
b. False
6. A study intended to collect single-dose PK data might be considered under 21 CFR 50.53 as a ________ if there is
adequate safety information to characterize the risk from exposure to the investigational drug and any additional study
procedures as no more than a ________.
a. minor increase over minimal risk/minor increase of over minimal risk
b. prospect of direct benefit/minor increase over minimal risk
c. minor decrease over minimal risk/prospect of direct benefit
d. minor increase over minimal risk/prospect of indirect benefit
7. Early inclusion of children in medical product development or initiation of clinical trials directly in children may be
inappropriate.
a. True
b. False
8. If the IRB determines that the procedure(s) is integral to answering the scientific question and ethical to perform, but
that it constitutes more than a minor increase over minimal risk, review under 21 CFR ________ will be required before the
clinical investigation may proceed.
a. 50.56
b. 50.52
c. 50.54
d. 50.53
9. Extending a dose for a product from another patient population (or different indication) to the new pediatric population
should be based on a sound scientific assessment, particularly addressing how the exposure-response for effectiveness
and safety in the other population was used to predict the exposure-response relationship in the pediatric population of
interest.
a. True
b. False
10. The available clinical data for the device (e.g., published studies and reports and actual use information) should be
considered when designing the clinical trial to minimize the amount of information gained and maximize the number of
subjects involved.
a. True
b. False
This self study qualifies for one hour of SOCRA CE (Continuing Education).
See answer key on page 24. Please retain this document for your CE record.
Name ________________________________________________________ Date __________________
SOCRA SOURCE © May 2023
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