最新的ACRP Certified Professional認證 ACRP-CP考試題庫

問題1

All of the following are examples of what monitors review EXCEPT:

A. The signed ICF retained in the participant's study file.

B. Regulatory binder which includes copies of current certifications for all laboratories.

C. Documentation in the participant's medical record of study drug administration.

D. Potential patient medical records for eligibility prior to the informed consent process.

正確答案: D

說明：（僅 VCESoft 成員可見）

問題2

IP is dispensed to all subjects who:

A. Need IP for their medical condition.

B. Consented for the trial.

C. Screened for the trial.

D. Are eligible to receive it in the trial.

正確答案: D

說明：（僅 VCESoft 成員可見）

問題3

In a quality management system, in which category do risk reduction activities belong?

A. Risk Communication

B. Risk Evaluation

C. Risk Control

D. Risk Review

正確答案: C

說明：（僅 VCESoft 成員可見）

問題4

A study protocol must contain which of the following elements?

A. Chemical structure of the IP

B. Participant reimbursement details

C. Description of statistical methods

D. Data management plan

正確答案: C

說明：（僅 VCESoft 成員可見）

問題5

The sponsor should supply a PI with the IP after:

A. Approval of protocol by the PI.

B. Approval of protocol by the sponsor.

C. Approval/favorable opinion from IRB/IEC and regulatory authority.

D. Submission of documents to IRB/IEC and regulatory authority for review.

正確答案: C

說明：（僅 VCESoft 成員可見）

問題6

A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A. Phase IV

B. Phase I

C. Phase II

D. Phase III

正確答案: C

說明：（僅 VCESoft 成員可見）

問題7

A subject became pregnant 16 weeks into a clinical trial. She has been taking a daily dose of IP since enrollment. The baby was born missing two toes on each foot. How should this be reported by the site?

A. This qualifies for prompt reporting to the IRB/IEC within 15 business days.

B. This needs to be reported to the patient's primary care physician.

C. This needs to be reported to the regulatory authorities within 10 business days.

D. This qualifies for expedited reporting to the sponsor.

正確答案: D

說明：（僅 VCESoft 成員可見）

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