ACRP Certified Professional : ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question #1
Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A. CRA
B. CRC
C. Sponsor
D. PI

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 the following should the site personnel do next?

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

Question #3
The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A. Inform participant and assure proper care is provided.
B. Schedule participant for early termination visit.
C. Inform the monitor of the termination of the study.
D. Inform the IRB/IEC of the study closure.

Question #4
Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A. Protocol, site coordinator CVs, and clinical trial agreement
B. Protocol, informed consent, and clinical trial agreement
C. IB, site coordinator CVs, and information about payments and compensation available to subjects
D. Protocol, IB, and information about payments and compensation available to subjects

Question #5
Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

A. Investigator
B. CRO
C. CRC
D. Sponsor

Solutions: