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| Section | Weight | Objectives |
|---|---|---|
| Clinical Study Operations | 15% | - Site management
|
| Ethical and Participant Safety Considerations | 19% | - Ethical principles
|
| Data Management and Informatics | 17% | - Data collection
|
| Regulatory and Compliance Requirements | 17% | - ICH Guidelines
|
| Professionalism and Ethical Practice | 15% | - Professional standards
|
| Study Design and Conduct | 17% | - Study planning
|
1. The PI should ensure that source data is:
A) On worksheets that are provided by the sponsor.
B) Accurately reflected in the eCRFs.
C) Kept on site for a minimum of 2 years.
D) Printed directly from the EMR.
2. 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 is taking part in too many ongoing studies to participate in this study.
B) No, the PI does not have the resources to perform all protocol-required procedures.
C) Yes, the PI can perform other imaging scans instead of the PET scans.
D) Yes, the PI has a sufficient patient population to take part in this study.
3. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:
A) Controlling risk by setting thresholds of risk acceptability.
B) Assessing risk based on study impact.
C) Documenting all possible risk scenarios.
D) Identifying potential study risks.
4. The inclusion and exclusion criteria are in place so all subjects are:
A) Patients with the disease under study and will not have any adverse events.
B) Healthy and willing to complete the clinical trial.
C) Medically appropriate and protected from ethical vulnerability.
D) Ethically vulnerable and patients with the disease under study.
5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) Applicable regulatory authorities
B) Sponsor
C) PI
D) Applicable site SOPs
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: B | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: A |
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