Last week, the CCTO launched Guidelines for shipment of self-administered drugs (oral and topical) to subjects unable to come to Stanford due to COVID-19 restrictions. The package of four documents (two guidelines and two forms) are posted in the CCTO website under Staff Resources for COVID-19:
- COVID‐19 Guidelines: CCTO Oral Medication Return
- CCTO Form for Sponsor Approval of Research Changes related to COVID-19
- CCTO Insert for Oral or Self-Administered Study Drug Shipment
- Shipping Self‐Administered Investigational Products to Research Subjects under COVID‐19 Restrictions
Prospective Stanford IRB approval is not required for shipping directly to subjects during the timeframe of COVID-19 constraints. The initiative is to be reported as a protocol modification as time allows.
Read all instructions carefully as study sponsor approval is required for shipment and approval process and contacts differ by study type.
Safe and appropriate management of drug necessary for shippers’ and recipient’s safety, and stability of the drug are key and may require special couriers.
Currently, there are no other alternative for in-person IP delivery than mail shipments. This is the only vested process approved by the School of Medicine Quality Office and Stanford Institutional review board (IRB).