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1. Per the protocol, participants' blood creatinine level must be no greater than 2.5 times the upper limit of normal (0.7-1.2 mg/dL). What is the maximum creatinine level the participant can have and be eligible for the trial?

A) 3.0 mg/dL
B) 2.6 mg/dL
C) 1.8 mg/dL
D) 3.6 mg/dL

2. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Pre-qualification assessment of CRO
B) Central monitoring of data fields by sponsor
C) Co-monitoring of CRO site visits
D) Risk-based audits of CRO activities as delegated

3. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A) The site may proceed with the destruction of the essential documents.
B) The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
C) The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
D) The site should retain the essential documents longer to meet the regulatory requirements.

4. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Any trial-related duties can be documented as transferred by verbal agreement.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) All duties transferred to a CRO should be specified in writing.
D) The IRB/IEC must approve the transfer of duties to a CRO.

5. Which of the following reports should be retained in participant charts?

A) DSMB/IDMC reports
B) Safety reports
C) Lab reports
D) IRB/IEC progress reports

問題與答案：