Study Returns and Close-Out

• Conduct correspondence and meet with sponsor monitors regularly.
• Assist in the investigation and reporting of adverse drug reactions.
• Collection of all patient drug returns and reconciliation.
• Participation in final close-out of the study protocol with the sponsor by providing copies of all drug disposition and inventory control records.
• Drug destruction policies in place to destroy expired or returned drug on site.
• Successful participation in ACTG, FDA, NCI, pharmaceutical manufacturer, and NIH audits.
• Storage of all terminated clinical drug study records for up to 5 years after closure.
• For further information, please review our Disposal of Investigational Agent.