최신SOCRA Certified Clinical Research Professional (CCRP) - CCRP무료샘플문제
문제1
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?
정답: B
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문제2
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?
After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?
정답: D
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문제3
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?
정답: C
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문제4
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
정답: D
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문제5
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
정답: A
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문제6
A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator's proposed patient recruitment materials?
A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator's proposed patient recruitment materials?
정답: C
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