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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Independent qualified individuals.
B) Investigators participating in the trial.
C) Executive board members.
D) Regulatory authority expert advisors.

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
B) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
C) A monitoring report that identifies deviation from the approved protocol.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

3. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Sponsor
B) Regulatory Agency
C) CRC
D) PI

4. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the subject.
B) Withdraw the subject.
C) Notify the regulatory authority.
D) Notify the sponsor.

5. A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A) This needs to be reported to the patient's primary care physician.
B) This qualifies for prompt reporting to the IRB/IEC within 15 business days.
C) This qualifies for expedited reporting to the sponsor.
D) This needs to be reported to the regulatory authorities within 10 business days.

Solutions: