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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A study protocol must contain which of the following elements?

A) Chemical structure of the IP
B) Data management plan
C) Participant reimbursement details
D) Description of statistical methods

2. The IB contains which of the following sections?

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

3. Which document confirms the PI's agreement to permit auditing at the study site?

A) IB
B) Protocol
C) ICF
D) Delegation Log

4. A serious unexpected ADR is one:

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

5. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) PI
B) Regulatory Agency
C) CRC
D) Sponsor

Solutions: