Free SOCRA CCRP Practice Test & Real Exam Questions
In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:
Correct Answer: B
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After completion of a Phase III trial, which document should IRB/IEC retain?
Correct Answer: B
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The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site's investigator has a subject actively receiving this study drug. Which of the following is the site investigator's responsibility to the subject?
Correct Answer: D
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According to ICH GCP, an electronic data capture (EDC) system must:
Correct Answer: C
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Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?
Correct Answer: C
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According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?
Correct Answer: B
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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?
Correct Answer: B
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