[Answer] Which monitoring visit would not include an inventory of investigational agents?

Answer: Prestudy site visit

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Which monitoring visit would not include an inventory of investigational agents? The FDA requires retention of investigational drug study records for: At least two years after the investigational drug's approval by the FDA . Which monitoring visit would NOT include an inventory of investigational agents? Fri May 25 2018 · Answer. 21 CFR 812 Investigational Device Exemptions would not include an inventory of investigational agents . It is a tool that's the topic of a clinical study to be utilized in order to gather safety and effectiveness information needed to support a pre-market approval (PMA) application or a pre-market notification. Subject 311 has had elevated white blood cell (WBC ) counts for the past two (2) study visits with no clinical signs or symptoms. " Increased WBC count " is not listed in the Investigator's Brochure (IB) as an adverse event. A systematic and independent examination of trial-related...

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