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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

2. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Administer rescue medication.
B) Call the medical monitor.
C) Consult the IB.
D) Report the AE to the sponsor.

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

4. A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A) A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
B) A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
D) A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population

5. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Redact subject identification for privacy protection.
B) Deny the request until the sponsor approves.
C) Allow access to the entire records.
D) Consult with the IRB/IEC first.

Solutions: