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ACRP-CP Dumps With Exact Questions and Answers

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ACRP-CP Questions and Answers

Question # 1

In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A.

A total of five members.

B.

One member whose primary area of interest is in the same scientific area.

C.

One member of the site's QA group.

D.

One member who is independent of the institution/trial site.

Question # 2

Who is responsible for the ongoing safety evaluation of the IP?

A.

Regulatory agency

B.

IRB/IEC

C.

Sponsor

D.

PI

Question # 3

A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year, 150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A.

Re-train investigators on recruitment obligations.

B.

Allocate additional monitoring resources to the trial.

C.

Reduce the target sample size based on feedback from the sites.

D.

Evaluate the screen failures to determine if the protocol needs revision.

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