- Dian Le
All CCTO clinical staff:
There is a new Guideline on how to request imaging from the SHC Film Library. Please review the guideline and check-out the new SU-13-Electronic form under Forms in the Coordinator Corner for imaging your requests. Thank you!
If you have questions regarding the new guideline, please contact your manager.
- Dian Le
For ease and accuracy of serious adverse event (SAE) reporting for investigator-initiated trials (IITs), CTTO-Regulatory is introducing additional IIT SAE report forms. These forms are variants of the current form, but allow attribution to multiple agents within a single form. The two new PDFs forms below are available on the Coordinator Corner under the Forms tab in addition to the initial form of one agent:
- Dian Le
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:
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).
- Dian Le
All CCTO Clinical Staff:
There is a new guideline available on the CCTO COVID-19 resources page:
Guideline for consent to changes in the research due to COVID-19
If you have questions regarding this guideline, please contact your manager.
- Dian Le
All CCTO clinical staff:
There is a new SOP document available on the CCTO Regulatory page:
Please review the SOP and retake the SOP Attestation to confirm that you have read it by April 10, 2020 or prior to use of remote consenting.
(This SOP is NOT applicable to non-English speaking remote consenting.)
If you have questions regarding remote consenting, please contact your manager.