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Study Site Monitoring

  1. Investigator Selection and Pre-Initiation Qualification
  2. Study Site Initiation and Regulatory Document Collection
  3. Investigator Meetings and/or Investigational Site Training
  4. Periodic Site Monitoring, Including Source Document Auditing, Compliance With GCPs, and Drug Accountability
  5. Data Review, Rectification, and Resolution
  6. Adverse Event Documentation and Reporting
  7. Close-out Study Site Visits and Study Termination
  8. Preparing a Study Site for a Regulatory Inspection

 

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Send mail to Michael Gendron, Ph.D. with questions or comments about this web site.
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Last modified: November 28, 2000

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