최신 CCRP 무료덤프 - SOCRA Certified Clinical Research Professional (CCRP)
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: B
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After randomization, investigational drug is shipped to site. Who is responsible for accountability?
정답: B
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An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?
정답: D
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In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?
정답: A
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A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?
정답: C
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A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?
정답: A
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