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Study Returns and Close-Out

  • Meet with sponsor monitors regularly.
  • Assist in the investigation and reporting of adverse drug reactions.
  • Collection of patient drug returns and reconciliation.
  • Participation in final close-out of the study protocol with the sponsor by providing copies of drug disposition and inventory control records.
  • Drug destruction policy in place to destroy expired or returned drug on site.
  • Successful participation in, FDA, NCI, pharmaceutical manufacturer, and NIH audits.