November 2024 SOCRA Source Journal - Journal - Page 10
SELF STUDY QUESTIONS
1. The FDA’s regulations for drug (including biologic) and device investigations have the same requirements for the submission of
informed consent materials.
a. True
b. False
2. An investigator may not begin the informed consent process with prospective subjects until the IRB reviews and approves
the clinical investigation, consent form, and any other information to be given to subjects as part of the consent process (21 CFR
50.20, 50.27, and 56.109).
a. True
b. False
3. The clinical investigator is responsible for protecting the subjects’ _________ during a clinical investigation, and for ensuring
that, unless an exception applies, legally effective informed consent is obtained from each subject or the subject’s LAR before that
subject takes part in the clinical investigation.
a. rights and safety
b. safety and welfare
c. rights, welfare, and safety
d. rights and welfare
4. The clinical investigator must provide the sponsor with a copy of the IRB-approved consent form.
a. True
b. False
5. Although the clinical investigator should consider issues regarding 昀椀nancial relationships and interests, IRBs have the 昀椀nal
responsibility of determining whether subjects should be provided with information regarding the _________ as part of the
informed consent process (see 21 CFR 56.109 and 56.111(a)(4)-(5)).
a. funding source
b. funding arrangements
c. 昀椀nancial interest of parties involved in the clinical investigation
d. all the above
6. Because the consent form is being modi昀椀ed to re昀氀ect new information that might affect the willingness of already enrolled and
actively participating subjects to continue in the clinical investigation, the IRB should determine the need to inform the previously
enrolled subjects of the new information and determine their willingness to continue in the research.
a. True
b. False
7. Even when a task is delegated to another individual, the _________ remains responsible for ensuring that legally effective
informed consent is obtained for all subjects in accordance with 21 CFR part 50).
a. sponsor
b. IRB
c. investigator
d. investigator’s staff
e. all the above
8. For other clinical investigations of drugs, the FDA often considers the following factors in determining whether to require
submission and review of the consent form:
a. The study subject population is particularly vulnerable.
b. The study design is usual for the therapeutic class.
c. The clinical investigation has signi昀椀cant potential for serious risks to human subjects.
d. All are correct.
e. Only a. and c.
9. If the investigator delegates the task of obtaining informed consent, the FDA expects that the individual to whom the
responsibility is delegated be quali昀椀ed by _________.
a. experience and training
b. training and education
c. education, training, and experience d. education
10. For multicenter clinical investigations reviewed by more than one IRB, when local IRB review results in substantive modi昀椀cations
to the consent form, i.e., changes that affect the rights, safety, or welfare of the subjects, FDA expects the sponsor to share the
revisions with all investigators and their IRBs.
a. True
b. False
This self study quali昀椀es for one hour of SOCRA CE (Continuing Education).
See answer key on page 21. Please retain this document for your CE record.
Name ________________________________________________________ Date __________________
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SOCRA SOURCE © November 2024
