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ACRP Certified Professional Sample Questions:

1. An interim analysis is conducted during a clinical trial. To review the results, the sponsor assigns:

A) Investigators participating in the trial.
B) Executive board members.
C) Regulatory authority expert advisors.
D) Independent qualified individuals.

2. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Health authority
C) Investigator
D) Sponsor

3. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) Yes, the PI has a sufficient patient population to take part in this study.
B) Yes, the PI can perform other imaging scans instead of the PET scans.
C) No, the PI is taking part in too many ongoing studies to participate in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.

4. 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.

5. Who is responsible for the ongoing safety evaluation of the IP?

A) IRB/IEC
B) Regulatory agency
C) PI
D) Sponsor

Solutions: