The Guideline for SAE Reporting for IITs has been updated (version 5, 12 December 2022). If you work on Stanford IITs, please review this guideline in detail to understand how to manage SAEs that occur on these trials.
If you have questions about the CCTO SAE form or reporting process, please contact CCTO-Safety@stanford.edu. If you have questions about regulatory requirements for safety reporting, please contact CCTO-Regulatory@stanford.edu. Any other questions should be directed to DSMC-Quality@stanford.edu.