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ACRP Certified Professional Sample Questions:

1. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A) When the need for the additional data is discovered
B) After the original planned data collection is completed
C) As soon as the protocol amendment is submitted to the IRB/IEC
D) After the protocol amendment is approved by the IRB/IEC

2. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Before accepting this site, report the risk to the trial sponsor and await their decision.
B) Accept this site and implement and maintain QA and QC systems with written SOPs.
C) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D) Accept this site and plan to undertake routine safety evaluations of the IP.

3. 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.

4. After the site qualification visit report has been finalized, it must be:

A) Stored in the sponsor's budgets and contracts file.
B) Sent to the IRB/IEC for review and approval.
C) Kept in the CRO/sponsor's trial master file.
D) Included in the PI's regulatory file.

5. The IB contains which of the following sections?

A) IP preparation instructions
B) Participant dosing schedule
C) Known pharmacokinetic effects
D) Participant eligibility criteria

Solutions: