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ACRP ACRP-CP 考試大綱主題:

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

1. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Occurrence of known side effects of the IP
B) Impact of an approved vaccine against the disease
C) Time to occurrence of symptoms of the disease
D) Use of concomitant medications to treat the symptoms

2. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Emerging animal toxicological and clinical data
B) Sample collection storage, disposal, and shipment requirements
C) PI roles and responsibilities
D) Project feasibility considerations

3. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Before accepting this site, report the risk to the trial sponsor and await their decision.
B) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
C) Accept this site and implement and maintain QA and QC systems with written SOPs.
D) Accept this site and plan to undertake routine safety evaluations of the IP.

4. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Consult with the IRB/IEC first.
B) Deny the request until the sponsor approves.
C) Allow access to the entire records.
D) Redact subject identification for privacy protection.

5. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Clinical Monitoring Plan
C) Data & Safety Monitoring Plan
D) Standard Operating Procedure

問題與答案：