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1. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?
A) IRB/IEC
B) CRO
C) Sponsor
D) Investigator
2. Who is responsible for submitting a protocol amendment to the IRB/IEC?
A) CRC
B) CRA
C) Sponsor
D) Investigator
3. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?
A) The IRB/IEC must approve the transfer of duties to a CRO.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) Any trial-related duties can be documented as transferred by verbal agreement.
D) All duties transferred to a CRO should be specified in writing.
4. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?
A) CRC
B) CRA
C) Sponsor
D) PI
5. In a quality management system, in which category do risk reduction activities belong?
A) Risk Communication
B) Risk Review
C) Risk Control
D) Risk Evaluation
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: D | Question # 5 Answer: C |
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