ACRP Certified Professional 認定 ACRP-CP 試験問題:
1. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?
A) Draft a CAPA plan
B) Establish a DSMB/IDMC
C) Conduct routine investigators' meetings
D) Develop a monitoring plan
2. Which of the following statements accurately describes the responsibilities of stakeholders involved in the conduct of a clinical study?
A) The CRC is responsible for identifying the relationship of an SAE to the IP.
B) The IRB/IEC is responsible for obtaining consent from all subjects in the clinical study.
C) The regulatory authority is responsible for assessing and approving the clinical study protocol and accompanying CRF prior to implementation.
D) The sponsor is responsible for overseeing any delegated activities to a CRO and ensuring that the delegation of these activities is documented.
3. 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) One member of the site's QA group.
B) A total of five members.
C) One member who is independent of the institution/trial site.
D) One member whose primary area of interest is in the same scientific area.
4. Which of the following statements is TRUE about an EDC system?
A) A separate workstation should be made available for the monitor.
B) The eCRF should be an exact page-by-page replica of the paper CRF.
C) There should be an audit trail to track data entries, deletions, and changes.
D) IRB/IEC approval is required before the use of the computerized system.
5. A PI is being considered for an industry-sponsored study. The PI sees approximately 20 patients per month who meet the study criteria. The PI does not have access to a Positron Emission Tomography (PET) scanner, which is required for the protocol. The PI is already taking part in three other studies. Should the Sponsor choose this PI?
A) No, the PI is taking part in too many ongoing studies to participate in this study.
B) Yes, the PI has a sufficient patient population to take part in this study.
C) No, the PI does not have the resources to perform all protocol-required procedures.
D) Yes, the PI can perform other imaging scans instead of the PET scans.
質問と回答：
| 質問 # 1 正解： B | 質問 # 2 正解： D | 質問 # 3 正解： C | 質問 # 4 正解： C | 質問 # 5 正解： C |
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