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OnCore entry of Serious Adverse Events (SAEs)

September 23, 2021 - SCI Communications

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

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