Exam (elaborations)
GCP TRAINING QUIZ
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Exam of 23 pages for the course GCP TRAINING at GCP TRAINING (GCP TRAINING QUIZ)
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GCP TRAINING QUIZ QUESTIONS WITHVERIFIED ANSWERS
oAfter the IRB reviews and approves your protocol, informed consent, and associated documents, you
should receive:
A. A phone call telling you the study can now proceed.
B. A personal visit from the IRB chair telling you how excited he/she is about your research.
C. Written notification of the IRB decision and the approved versions of the protocol and informed
consent forms.
D. Nothing. If you do not receive a response in 30 days, you can proceed with your study. - C. Written
notification of the IRB decision and the approved versions of the protocol and informed consent forms.
4An IRB may perform an expedited review of a protocol or informed consent form change if the change
involves no more than minimal risk to study participants.
A. TRUE
B. FALSE - A. TRUE
2For an IRB review to be required, clinical research must be:
A. Federally funded.
B. Involve a product regulated by the FDA.
C. Fall under local institutional rules requiring IRB approval.
D. Any or all of the above A, B or C. - D. Any or all of the above A, B or C.
3The primary purpose of the Institutional Review Board (IRB) is to:
A. Investigate allegations of research misconduct.
B. Administer compensation for participation to study volunteers.
C. Protect the rights and welfare of research participants.
D. All of the above. - D. All of the above.
1A protocol that has been previously reviewed by the full IRB is always eligible for expedited review.
A. TRUE
B. FALSE - B. FALSE
,1The three key principle(s) that underlie the current system of human research protections include
which of the following?
A. Respect for persons
B. Beneficence
C. Justice
D. Honor
E. All of the above.
F. A, B, and C - F. A, B, and C
2The purpose of an IRB is to safeguard the rights, safety, and well-being of all human research
participants.
A. TRUE
B. FALSE - A. TRUE
3IRB members must:
A. All be physicians who can assess subject safety.
B. Be affiliated with the institute or study site conducting the study.
C. Have the qualifications and experience to review and evaluate the scientific, medical, behavioral,
social, legal, ethical, and non-scientific aspects of a proposed study.
D. Be investigators on the study - C. Have the qualifications and experience to review and evaluate the
scientific, medical, behavioral, social, legal, ethical, and non-scientific aspects of a proposed study.
4An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint.
Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering
dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw.
This change can be implemented:
A. Immediately, as it is not a safety assessment.
B. Once the protocol is finalized and submitted to the FDA.
C. Once the protocol and consent form updates are approved by the IRB.
D. As soon as the study sponsor advises that their decision is final to remove these blood draws. - C.
Once the protocol and consent form updates are approved by the IRB
What information should be provided to an IRB for review at the initiation of a study? Choose the best
response.
, A. A synopsis of the study and an outline of the advertisement to recruit subjects, including how much
they will be paid.
B. The informed consent form.
C. The study protocol (and amendments), the information to be given to the subject (informed consent,
advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and an
outline of the qualifications of the lnvestigator.
D. The study protocol (and amendments) and the Investigator Brochure. - C. The study protocol (and
amendments), the information to be given to the subject (informed consent, advertisements), the
Investigator Brochure (or drug label), any other relevant safety information, and an outline of the
qualifications of the lnvestigator.
2Because of being incarcerated, prisoners may not be able to make a voluntary decision about
participating in a clinical trial.
A. TRUE
B. FALSE - A. TRUE
The Informed Consent form can be used to consent research participants before the IRB reviews and
approves the language.
A. TRUE
B. FALSE - B. FALSE
4If the research participant is a minor (under the age of 18), which of the following must occur before
the individual can participate in the research study?
A. The parent/legal guardian must give permission for the minor to participate.
B. The minor must agree to participate in the research.
C. A judge gives permission for the minor to participate in the research.
D. A and B
E. A, B, and C - A. The parent/legal guardian must give permission for the minor to participate.
The consent form is signed by the participant but is missing the participant's initials in several places.
Which strategy helps to prevent this from occurring in the future with other participants?
A. Conduct consent interviews in a quiet, separate room with no distractions or interruptions.
B. The person obtaining the participant's consent must be present when the form is signed.
C. Create and use a checklist to ensure that every detail in the informed consent process is completed.
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