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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A) Rely on the sponsor to notify the IRB/IEC.
B) Use a central IRB/IEC.
C) Recruit for the study without use of social media.
D) Decline the study.

2. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Central monitoring of data fields by sponsor
B) Risk-based audits of CRO activities as delegated
C) Co-monitoring of CRO site visits
D) Pre-qualification assessment of CRO

3. 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) Sponsor
B) QA Department
C) Monitor
D) Data Manager

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

5. 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) Regulatory authority expert advisors.
D) Executive board members.

Solutions: