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| Section | Weight | Objectives |
|---|---|---|
| Regulatory and Compliance Requirements | 17% | - International standards
|
| Study Design and Conduct | 17% | - Study implementation
|
| Clinical Study Operations | 15% | - Project management
|
| Data Management and Informatics | 17% | - Data collection
|
| Professionalism and Ethical Practice | 15% | - Continuous improvement
|
| Ethical and Participant Safety Considerations | 19% | - Clinical care and management of research participants
|
1. 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 cannot be the PI on the clinical study due to conflict of interest.
B) They can attend the meeting and can vote/provide opinion on whether to approve the study.
C) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
D) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
2. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?
A) Monitor
B) Coordinator
C) Sponsor
D) Investigator
3. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
A) No, the PI does not have the resources to perform all protocol-required procedures.
B) No, the PI is taking part in too many ongoing studies to participate in this study.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) Yes, the PI can perform other imaging scans instead of the PET scans.
4. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
A) CRO
B) Sponsor
C) CRC
D) Investigator
5. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:
A) Allowing real-time access for data review in the eCRF.
B) Recording the date and time each data element is entered onto the source document.
C) Comparing source document data to other data recorded in the same study time period.
D) Recording data on source documents at the time the data are collected during the conduct of the study.
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: B | Question # 5 Answer: D |
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