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Question 1 of 5
1. Question
In assessing compliance with ICH/GCP guidelines and Federal regulations, the following are three components of a monitoring visit:
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Question 2 of 5
2. Question
From a regulatory perspective, in preparation for a monitoring visit the research team should ensure that the following are in order:
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Question 3 of 5
3. Question
According to the ACRP Checklist of Tasks for Monitoring Visits, the monitor will review the following:
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Question 4 of 5
4. Question
The clinical research coordinator, the pharmacist, the site PI, and the overall awardee PI should all be present and engaged in the monitoring visit.
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Question 5 of 5
5. Question
In reviewing serious adverse events (SAEs), the severity of the event is always determined by:
