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| Section | Objectives |
|---|---|
| Topic 1: Professional Responsibilities | - Communication and collaboration
|
| Topic 2: Quality Management | - Audit and inspection readiness
|
| Topic 3: Clinical Trial Operations | - Study conduct
|
| Topic 4: Data Management and Documentation | - Data integrity
|
| Topic 5: Ethical and Participant Safety Considerations | - Human subject protection
|
1. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?
A) Blinding
B) Privacy controls
C) Placebo-controlled
D) Randomization
2. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
A) CRO
B) CRC
C) Sponsor
D) Investigator
3. When assessing the monitoring needs for a study, sponsors should:
A) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
B) Use central monitoring instead of conducting physical monitoring visits at sites.
C) Permit PIs to select a monitor for their site as long as they are independent of the PI.
D) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
4. Source data/documentation should be:
A) Attributable, legible, contemporaneous, original, accurate, and complete.
B) Attributable, legible, correct, original, accurate, and clear.
C) Attributable, legible, correct, original, accurate, and complete.
D) Attributable, legible, contemporaneous, original, accurate, and clear.
5. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?
A) Ship/receive IP
B) Obtain IRB/IEC approval
C) Verify subject eligibility
D) Schedule a site initiation visit
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: B |
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