Handling of Controlled Substances: 21 CFR 312.69

If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked, substantially constructed enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.

We at DSI have several precautions to adhere to this code, including:

1. The secure place our office is in.
2. The Hospital patrols the office night and day.
3. The building and the elevator are locked after hours.
4. The office is locked and alarmed.
5. The study drug is in a locked room with limited access.
6. We have custom locked cabinets bolted to the wall that contain a second locked cabinet bolted to the wall.
7. Melody is the only one with the key. She has ongoing training to ensure drug safety. Smitha and Melody made up an SOP on the particulars how study drug is received, recorded in IVRS (if applicable) and dispensed.