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ACRP Certified Professional Sample Questions:

1. 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.

2. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?

A) Yes, the PI can perform other imaging scans instead of the PET scans.
B) No, the PI is taking part in too many ongoing studies to participate in this study.
C) Yes, the PI has a sufficient patient population to take part in this study.
D) No, the PI does not have the resources to perform all protocol-required procedures.

3. Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

A) Investigator
B) Monitor
C) Coordinator
D) Sponsor

4. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A) CRA
B) PI
C) CRC
D) Sponsor

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

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

Solutions: