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| Section | Objectives |
|---|---|
| Quality Management | - Audit and inspection readiness
|
| Clinical Trial Operations | - Study start-up activities
|
| Professional Responsibilities | - Leadership and professionalism
|
| Data Management and Documentation | - Clinical trial documentation
|
| Ethical and Participant Safety Considerations | - Human subject protection
|
1. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?
A) Data Manager
B) CRA
C) CRO
D) Sponsor
2. Who ensures information regarding payments to subjects is documented in a written consent form?
A) IRB/IEC
B) Coordinator
C) PI
D) Sponsor
3. A monitor identifies multiple deviations from a protocol-defined timeline for study procedures. The monitor is unable to identify proof of PI review and assessment of the deviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What is the purpose of this CAPA?
A) To determine if the deviations invalidate the data
B) To escalate corrective actions to the regulatory authority
C) To establish a procedure for PI oversight of protocol deviations
D) To determine if a protocol amendment is needed
4. 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 cannot be the PI on the clinical study due to conflict of interest.
C) They can attend the meeting and can vote/provide opinion on whether to approve the study.
D) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
5. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?
A) Standard Operating Procedure
B) Data & Safety Monitoring Plan
C) Investigator's Brochure
D) Clinical Monitoring Plan
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: A | Question # 3 Answer: C | Question # 4 Answer: A | Question # 5 Answer: A |
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