ACRP ACRP-CP Questions Answers
ACRP Certified Professional Exam- 125 Questions & Answers
- Update Date : October 19, 2026
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ACRP ACRP-CP Sample Questions
Question # 1After the site qualification visit report has been finalized, it must be:
A. Kept in the CRO/sponsor's trial master file.
B. Included in the PI's regulatory file.
C. Stored in the sponsor's budgets and contracts file.
D. Sent to the IRB/IEC for review and approval.
Question # 2
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 thefollowing 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.
Question # 3
AEs that occur between study visits of a clinical trial should be evaluated by the:
A. Subject's primary care physician
B. Principal Investigator
C. Medical monitor
D. Study pharmacovigilance physician
Question # 4
Who must be blinded in a double-blind study in order to prevent bias?
A. Pharmacist
B. Subject
C. Data entry staff
D. IRB/IEC
Question # 5
A study subject inadvertently disposed of IP medication bottles. The site should report thisto the:
A. Sponsor.
B. IRB/IEC.
C. Medical monitor.
D. Regulatory authority.
Question # 6
Which of the following documents is maintained by a PI to ensure compliance with sponsorrequirements?
A. Regulatory submission of protocol and accompanying documents to relevant regulatoryauthority.
B. A monitoring report that identifies deviation from the approved protocol.
C. A monitoring plan that is tailored to the specific human subject protection and dataintegrity risks of the trial.
D. Training records of site personnel on study protocol, and their study-related duties andfunctions.
Question # 7
A PI on a study is a regular member of the IRB/IEC. Which of the following statements isTRUE regarding their participation in the IRB/IEC discussion and deliberation?
A. They cannot be the PI on the clinical study due to conflict of interest.
B. They can attend the meeting and can vote/provide opinion on whether to approve thestudy.
C. They must recuse themselves from the meeting given their dual roles as IRB/IECmember and PI.
D. They can attend the meeting, but should not vote/provide opinion on whether to approvethe study.
Question # 8
After the completion or termination of a clinical trial, who should store the enrollment log?
A. PI
B. CRO
C. Sponsor
D. Regulatory authority
Question # 9
A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At theend of the first year, 150 subjects have been enrolled. Monitoring reports from the first yearnote 50% of subjects screened were screen failures due to exclusionary lab values. Whataction should the sponsor take?
A. Re-train investigators on recruitment obligations.
B. Allocate additional monitoring resources to the trial.
C. Reduce the target sample size based on feedback from the sites.
D. Evaluate the screen failures to determine if the protocol needs revision.
Question # 10
Who ensures information regarding payments to subjects is documented in a writtenconsent form?
A. Coordinator
B. IRB/IEC
C. PI
D. Sponsor
Question # 11
A monitor identifies multiple deviations from a protocol-defined timeline for studyprocedures. The monitor is unable to identify proof of PI review and assessment of thedeviations. The monitor discusses the deviations with the PI, who initiates a CAPA. What isthe purpose of this CAPA?
A. To determine if a protocol amendment is needed
B. To escalate corrective actions to the regulatory authority
C. To determine if the deviations invalidate the data
D. To establish a procedure for PI oversight of protocol deviations
Question # 12
In order to conduct open-label, parallel group clinical trials according to sound scientificprinciples, which of the following design elements should be included?
A. Randomization
B. Privacy controls
C. Blinding
D. Placebo-controlled
Question # 13
Who is responsible for submitting a protocol amendment to the IRB/IEC?
A. Sponsor
B. CRC
C. Investigator
D. CRA
Question # 14
Which statement does NOT represent a study monitor's responsibilities?
A. Check the accuracy and completeness of case report forms with source documents.
B. Provide communication between the sponsor and the PI.
C. Report serious adverse events to the IRB/IEC.
D. Verify that the PI has adequate qualifications and resources to conduct the study.
Question # 15
An investigator participating in a multicenter clinical trial has had 2 of the 4 subjectsadmitted to the emergency room for life-threatening infections. The investigator made thedecision to stop treatment with IP and test for infections in the remaining subjects. Whatare the NEXT steps the investigator should take?
A. Add the risk of infection to the ICF and submit to the IRB/IEC for review.
B. Update the IB to add the risk of infection and submit to the sponsor for approval.
C. Notify the sponsor of the change in study plan and submit the deviation to the IRB/IECfor review.
D. Discontinue current subjects from the study and monitor subjects for any anticipatedsafety events.