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最新的 ACRP Certified Professional ACRP-CP 免費考試真題:

1. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The CRC should amend the medical chart.
B) The PI should notify the monitor.
C) The PI should amend the medical chart.
D) The CRC should write a note to file.

2. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Train the research coordinator on the required study assessments schedule.
B) Identify critical processes and data during protocol development.
C) Perform a periodic review to see if the quality methods are effective and relevant.
D) Determine the quality tolerance limits for data transcription errors.

3. At a close-out visit, which document should be retained only at the site?

A) Final trial close-out monitoring report
B) Subject identification code list
C) IP accountability
D) Treatment allocation

4. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) IRB/IEC
C) Subject
D) Data entry staff

5. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 71%
B) 77%
C) 66%
D) 80%

問題與答案：