GCP TRAINING QUIZ WITH
COMPLETE SOLUTIONS
After 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. - Correct Answers -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 - Correct Answers -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. - Correct Answers -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. - Correct Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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. - Correct Answers -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. - Correct
Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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.
D. All of the above. - Correct Answers -A. Conduct consent interviews in a quiet,
separate room with no distractions or interruptions.
4When an original consent form has been lost, the only steps that must be taken are
that study staff report the loss immediately to the IRB, the sponsor, and get another
signed as soon as possible.
A. TRUE
B. FALSE - Correct Answers -A. TRUE
There are many historical examples of blatant coercion where:
A. Participants believed that they would be harmed or punished for refusing to take part
in research.
B. Relationships existed that involved dependence or unequal power between those
carrying out the research and potential participants.
COMPLETE SOLUTIONS
After 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. - Correct Answers -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 - Correct Answers -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. - Correct Answers -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. - Correct Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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. - Correct Answers -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. - Correct
Answers -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 - Correct Answers -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 - Correct Answers -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 - Correct Answers -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.
D. All of the above. - Correct Answers -A. Conduct consent interviews in a quiet,
separate room with no distractions or interruptions.
4When an original consent form has been lost, the only steps that must be taken are
that study staff report the loss immediately to the IRB, the sponsor, and get another
signed as soon as possible.
A. TRUE
B. FALSE - Correct Answers -A. TRUE
There are many historical examples of blatant coercion where:
A. Participants believed that they would be harmed or punished for refusing to take part
in research.
B. Relationships existed that involved dependence or unequal power between those
carrying out the research and potential participants.
