SOCRA CCRP Practice Exam 2025 – 400 Free Practice Questions to Pass the Exam

Question: 1 / 400

What does ICH GCP 5.18.3 state about monitoring of investigators by sponsors?

Trials need not be monitored

Monitoring should be minimized

Trials should be adequately monitored

ICH GCP 5.18.3 states that trials should be adequately monitored by sponsors, which means that sponsors are responsible for ensuring that the trials are being conducted according to proper protocols and regulations. Options A and B are incorrect because they suggest that monitoring is not necessary or should be limited, which goes against the guidelines of ICH GCP. Option D is also incorrect because while the FDA may conduct inspections and audits, it is not solely responsible for monitoring investigators in clinical trials. Overall, the correct answer highlights the importance of sponsors monitoring investigators to ensure the integrity and accuracy of clinical trial data.

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Monitoring is the responsibility of the FDA

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