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ACRP Certified Professional Sample Questions:

1. The PI should ensure that source data is:

A) Accurately reflected in the eCRFs.
B) On worksheets that are provided by the sponsor.
C) Kept on site for a minimum of 2 years.
D) Printed directly from the EMR.

2. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

A) CRA
B) Investigator
C) CRC
D) Sponsor

3. A sponsor writes a protocol comparing an IP XYZ to a marketed drug ABC to determine if XYZ is more efficacious in the target population than ABC. Both drugs are prepared in identically masked IV bags and distributed according to the randomization scheme outlined in the protocol such that the study team is unaware of the treatment assignment.
Which of the following is an appropriate title for this study?

A) A randomized, open-label, comparator study comparing the efficacy of XYZ to ABC in the target population
B) A randomized, single-blind, placebo-controlled study comparing the efficacy of XYZ to ABC in the target population
C) A randomized, double-blind, double-dummy, superiority study comparing the efficacy of XYZ to ABC in the target population
D) A randomized, double-blind, superiority study comparing the efficacy of XYZ to ABC in the target population

4. The inclusion and exclusion criteria are in place so all subjects are:

A) Medically appropriate and protected from ethical vulnerability.
B) Ethically vulnerable and patients with the disease under study.
C) Patients with the disease under study and will not have any adverse events.
D) Healthy and willing to complete the clinical trial.

5. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A) CRA
B) IRB/IEC
C) PI
D) CRC

Solutions: