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Updated: May 30, 2026
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1. What would a sponsor use to implement and maintain quality in a study?
A) Statistical analysis plan
B) Standard operating procedures
C) Protocol signature pages
D) Clinical trial agreement
2. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?
A) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
B) They can attend the meeting and can vote/provide opinion on whether to approve the study.
C) They cannot be the PI on the clinical study due to conflict of interest.
D) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
3. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?
A) IB, site coordinator CVs, and information about payments and compensation available to subjects
B) Protocol, IB, and information about payments and compensation available to subjects
C) Protocol, informed consent, and clinical trial agreement
D) Protocol, site coordinator CVs, and clinical trial agreement
4. The IB contains which of the following sections?
A) Known pharmacokinetic effects
B) IP preparation instructions
C) Participant eligibility criteria
D) Participant dosing schedule
5. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?
A) CRA
B) PI
C) Sponsor
D) CRC
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: A | Question # 3 Answer: B | Question # 4 Answer: A | Question # 5 Answer: B |
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