最新的ACRP ACRP-CP免費考試真題

問題1

A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A. Any trial-related duties can be documented as transferred by verbal agreement.

B. All duties transferred to a CRO should be specified in writing.

C. Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.

D. The IRB/IEC must approve the transfer of duties to a CRO.

正確答案: B

說明：（僅 Fast2test 成員可見）

問題2

In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A. CRC

B. PI

C. CRA

D. IRB/IEC

正確答案: B

說明：（僅 Fast2test 成員可見）

問題3

Source data/documentation should be:

A. Attributable, legible, contemporaneous, original, accurate, and complete.

B. Attributable, legible, correct, original, accurate, and clear.

C. Attributable, legible, correct, original, accurate, and complete.

D. Attributable, legible, contemporaneous, original, accurate, and clear.

正確答案: A

說明：（僅 Fast2test 成員可見）

問題4

An impartial witness should be present during the entire informed consent discussion when:

A. A parent/guardian is consenting for a minor subject.

B. A subject has been determined to be vulnerable.

C. A legally acceptable representative is unable to read.

D. An interpreter is translating the consent form for a subject.

正確答案: C

說明：（僅 Fast2test 成員可見）

問題5

Which strategy is used to safeguard subject privacy?

A. Utilize subject initials on correspondence.

B. Conduct subject-related conversations in controlled environments.

C. Store source documentation in the CRC's office.

D. Email updated enrollment logs to the CRA.

正確答案: B

說明：（僅 Fast2test 成員可見）

問題6

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

A. Protocol

B. ICF

C. Delegation Log

D. IB

正確答案: B

說明：（僅 Fast2test 成員可見）

最新的ACRP Certified Professional - ACRP-CP免費考試真題

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