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ACRP Certified Professional Sample Questions:

1. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Project feasibility considerations
B) PI roles and responsibilities
C) Emerging animal toxicological and clinical data
D) Sample collection storage, disposal, and shipment requirements

2. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 8 calendar days
B) 7 calendar days
C) 30 calendar days
D) 15 calendar days

3. The IB contains which of the following sections?

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

4. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Parallel Group
B) Group sequential
C) Factorial
D) Crossover

5. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Medical monitor
B) Study pharmacovigilance physician
C) Subject's primary care physician
D) Principal Investigator

Solutions: