Since November 2019, CCTO-Safety does not process any Serious Adverse Events (SAEs) for Industry sponsored trials into OnCore. Do not send SAE reports to CCTO-Safety for Industry sponsored trials.
CCTO-Safety will only process SAEs reports for Investigator-Initiated Trials into OnCore.
The Regulatory SOP and guideline documents have been updated. Also, the SAE CRFs (3 forms) are updated and uploaded. https://med.stanford.edu/ccto/staff-resources/coordinator-corner.html#regulatory