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 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.
- Storage of all completed clinical drug study records for up to 5 years after study closure.
- For further information, please review our Disposal of Investigational Agent.