Monitoring Clinical Trials Of Drugs By Industry Sponsors Quiz

25 July 2022
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question
All unused investigational agents are expected to be returned to the sponsor at the:
answer
Termination site visit.
question
Which of the following should take place during periodic site visits?
answer
Identification of protocol violations
question
Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?
answer
Periodic site visits
question
When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?
answer
Site initiation visit
question
The FDA requires retention of investigational drug study records for:
answer
At least two years after the investigational drug's approval by the FDA.
question
Which monitoring visit would NOT include an inventory of investigational agents?
answer
Prestudy site visit