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ACRP Certified Professional Sample Questions:

1. One key attribute for good study documentation is that the data are contemporaneous, which refers to the practice of:

A) Recording data on source documents at the time the data are collected during the conduct of the study.
B) Comparing source document data to other data recorded in the same study time period.
C) Recording the date and time each data element is entered onto the source document.
D) Allowing real-time access for data review in the eCRF.

2. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Update the IB to add the risk of infection and submit to the sponsor for approval.
B) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
C) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
D) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.

3. The investigator/institution should permit:

A) Monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies).
B) Monitoring and inspection by the appropriate regulatory authority(ies), and auditing by the sponsor.
C) Monitoring and auditing by the appropriate regulatory authority(ies), and inspection by the sponsor.
D) Monitoring and inspection by the sponsor, and auditing by the appropriate regulatory authority(ies).

4. What is a systematic and independent examination of trial-related activities and documents todetermine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsors, SOPs, GCP, and the applicable regulatory requirements?

A) Audit
B) Inspection
C) Site qualification
D) Routine monitoring

5. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Impact of an approved vaccine against the disease
B) Occurrence of known side effects of the IP
C) Use of concomitant medications to treat the symptoms
D) Time to occurrence of symptoms of the disease

Solutions: