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ACRP Certified Professional Sample Questions:

1. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Under the supervision of the PI.
B) An employee of the institution.
C) Approved by the IRB/IEC.
D) Licensed to practice medicine.

2. The IB contains which of the following sections?

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

3. 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) 2.6 mg/dL
B) 1.8 mg/dL
C) 3.0 mg/dL
D) 3.6 mg/dL

4. A serious unexpected ADR is one:

A) That results in the death of the subject.
B) That does not need to be reported to the IRB/IEC.
C) Where the severity of the reaction is not consistent with IB.
D) Severity and nature of the reaction is consistent with protocol.

5. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval of protocol by the PI.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval/favorable opinion from IRB/IEC and regulatory authority.

Solutions: