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ACRP Certified Professional Sample Questions:

1. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Coordinator
B) Investigator
C) Sponsor
D) Monitor

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

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

3. When assessing the monitoring needs for a study, sponsors should:

A) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
B) Permit PIs to select a monitor for their site as long as they are independent of the PI.
C) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
D) Use central monitoring instead of conducting physical monitoring visits at sites.

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

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

5. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A) Re-train investigators on recruitment obligations.
B) Allocate additional monitoring resources to the trial.
C) Evaluate the screen failures to determine if the protocol needs revision.
D) Reduce the target sample size based on feedback from the sites.

Solutions: