ACRP Certified Professional Exam (ACRP-CP) Free Practice Test

Question 1

Who should vote during the IRB/IEC review and discussion process?

A. All members who were involved in the review and discussion and non-member experts

B. All members who were involved in the review and discussion

C. All IRB/IEC members and non-member experts

D. All IRB/IEC members

Correct Answer: B

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Question 2

After the site qualification visit report has been finalized, it must be:

A. Sent to the IRB/IEC for review and approval.

B. Kept in the CRO/sponsor's trial master file.

C. Included in the PI's regulatory file.

D. Stored in the sponsor's budgets and contracts file.

Correct Answer: B

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Question 3

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

A. Protocol

B. IB

C. Delegation Log

D. ICF

Correct Answer: D

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Question 4

A deferred consent can take place in which of the following situations?

A. In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.

B. Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

C. Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.

D. In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

Correct Answer: D

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Question 5

Who takes responsibility for initiating a clinical trial?

A. IRB/IEC

B. Investigator

C. CRO

D. Sponsor

Correct Answer: D

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Question 6

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

Correct Answer: D

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ACRP Certified Professional (ACRP-CP) Free Practice Test