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ACRP Certified Professional Sample Questions:
1. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?
A) Impact of an approved vaccine against the disease
B) Occurrence of known side effects of the IP
C) Time to occurrence of symptoms of the disease
D) Use of concomitant medications to treat the symptoms
2. Which statement does NOT represent a study monitor's responsibilities?
A) Verify that the PI has adequate qualifications and resources to conduct the study.
B) Provide communication between the sponsor and the PI.
C) Report serious adverse events to the IRB/IEC.
D) Check the accuracy and completeness of case report forms with source documents.
3. Who ensures information regarding payments to subjects is documented in a written consent form?
A) Coordinator
B) Sponsor
C) PI
D) IRB/IEC
4. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?
A) QA Department
B) Sponsor
C) Monitor
D) Data Manager
5. What would a sponsor use to implement and maintain quality in a study?
A) Protocol signature pages
B) Standard operating procedures
C) Statistical analysis plan
D) Clinical trial agreement
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: C | Question # 5 Answer: B |



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