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Exam ACRP-CP Topic 1 Question 54 Discussion

Actual exam question for ACRP's ACRP-CP exam
Question #: 54
Topic #: 1
Which statement does NOT represent a study monitor's responsibilities?

Suggested Answer: C Vote an answer

It is not the monitor's responsibility to report serious adverse events (SAEs) to the IRB/IEC. This responsibility typically falls on the PI or the sponsor. Monitors focus on data accuracy, protocol compliance, and communication between the site and the sponsor.
The answer follows GCP standards where the monitor's role is clearly defined, excluding SAE reporting to IRB/IEC.
"Monitors are responsible for verifying data accuracy and communicating with the sponsor but not for direct reporting of SAEs to the IRB/IEC." Objectives:
* Distinguish between the responsibilities of monitors and investigators
* Clarify SAE reporting protocols

by Jason at Jul 01, 2026, 06:38 PM

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