Regulations, Monitoring, and Documentation
The IDS consistently meets the regulation requirements of sponsors, the FDA, Florida Board of Pharmacy, and other regulatory agencies.
We use SensoScientific® for temperature monitoring and control and Vestigo® for protocol-specific pharmacy documentation electronic management, patient enrollment, dispensations, and drug accountability.
The IDS maintains a USP797 cleanroom standards for compounding nonhazardous and hazardous IV drugs. We store all investigational medications within a protocol-assigned bin in its designated control area.
Vestigo® access
Vestigo® is a digital, paperless documentation system that allows monitors to conduct remote reviews when given access to pharmacy records.
To gain access to Vestigo®, review the Vestigo® Verify Manual. Each time IDS provides access, the monitor receives an email from Vestigo® with login information. Once access is granted, monitors can click the “View Protocol link” (to the right of the visit notification) to review and conduct the following:
- Protocol – protocol overview
- Inventory – overall inventory and add visit notes
- Returns – patient returns and authorize destruction or return to sponsor
- Documents – shipping invoices, protocols, pharmacy manuals, training documentation, correspondences from sponsor
- Accountability – obtain accountability logs (IDARs)
- Visit Notes – add notes specific to the visit
- Monitor Review – review transactions related to each drug item
- Audit Log – IDS audit trail for review
- Temperature documents – temperature logs and calibration certificates for each drug storage location
- Reports – protocol-specific reports
To accommodate scheduling, IDS maintains a calendar for monitors. Click here to access the site monitor visit schedule. For more information, visit the Vestigo® Accountability system website.
