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ACRP Certified Professional Sample Questions:
1. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) PI
B) Applicable site SOPs
C) Sponsor
D) Applicable regulatory authorities
2. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?
A) Ensure submission of a data management plan to the regulatory authorities.
B) Conduct annual reviews of the protocol and accompanying study documents.
C) Ensure there is an accompanying written record that describes the consent process.
D) Develop a plan that describes the monitoring approach for a clinical study.
3. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?
A) Submit the diary to the regulatory authority for approval.
B) Submit the diary to the sponsor for approval.
C) Submit the diary to the IRB/IEC for approval.
D) No approval is necessary: give the diary to each subject.
4. In a quality management system, in which category do risk reduction activities belong?
A) Risk Evaluation
B) Risk Communication
C) Risk Review
D) Risk Control
5. When designing a clinical trial, why is it important to define the study population?
A) To determine the study objectives
B) To support subject recruitment to the study
C) To support the study objectives
D) To determine where to conduct the study
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: D | Question # 5 Answer: C |
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