Monitoring Clinical Trials of Drugs by Industry Sponsors Quizzes

All unused investigational agents are expected to be returned to the sponsor at the: Termination site visit. Which of the following should take place during periodic site visits? Identification of protocol violations Which of the following best describes when the majority of case report form (CRF) data are verified against source record information? Periodic site visits When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff? Site initiation visit 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? Prestudy site visit Which of the following is required at a prestudy site visit? ...