ACRP-CP 무료 덤프문제 온라인 액세스

The sponsor should supply a PI with the IP after:

• A.Approval/favorable opinion from IRB/IEC and regulatory authority.
• B.Submission of documents to IRB/IEC and regulatory authority for review.
• C.Approval of protocol by the sponsor.
• D.Approval of protocol by the PI.

The coding system for a double-blind clinical trial is accessible by the:

• A.PI
• B.Regulatory authority
• C.IRB/IEC
• D.Sponsor

The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

• A.The CRC should write a note to file.
• B.The PI should notify the monitor.
• C.The PI should amend the medical chart.
• D.The CRC should amend the medical chart.

In a quality management system, in which category do risk reduction activities belong?

• A.Risk Control
• B.Risk Evaluation
• C.Risk Communication
• D.Risk Review

Who ensures information regarding payments to subjects is documented in a written consent form?

• A.Coordinator
• B.PI
• C.IRB/IEC
• D.Sponsor