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ACRP Certified Professional Sample Questions:

1. Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A) 3.6 mg/dL
B) 2.6 mg/dL
C) 1.8 mg/dL
D) 3.0 mg/dL

2. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Data Manager
B) QA Department
C) Sponsor
D) Monitor

3. Who on the local site research study team is accountable for the unblinding documentation of IP?

A) Regulatory manager
B) PI
C) CRC
D) Pharmacist

4. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) Sponsor-Investigator
B) Regulatory authority
C) CRO
D) IRB/IEC

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

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

Solutions: