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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A) Ensure submission of a data management plan to the regulatory authorities.
B) Develop a plan that describes the monitoring approach for a clinical study.
C) Ensure there is an accompanying written record that describes the consent process.
D) Conduct annual reviews of the protocol and accompanying study documents.

2. SAEs must be reported immediately by the site to the:

A) DSMB/IDMC.
B) Regulatory agency.
C) Sponsor.
D) IRB/IEC.

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

4. Source data/documentation should be:

A) Attributable, legible, correct, original, accurate, and complete.
B) Attributable, legible, contemporaneous, original, accurate, and clear.
C) Attributable, legible, contemporaneous, original, accurate, and complete.
D) Attributable, legible, correct, original, accurate, and clear.

5. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Sample collection storage, disposal, and shipment requirements
B) Project feasibility considerations
C) PI roles and responsibilities
D) Emerging animal toxicological and clinical data

Solutions: