Consistent with the new SCI Data Safety and Monitoring Plan, Serious adverse event (SAE) entry into OnCore is changing for investigator-initiated studies (IIS/IIT). There are 2 major changes.
- The DSMC will review all SAEs (new and follow‑ups), instead of the previous criteria of SAEs Grade 3 and higher. All SAEs regardless of grade should be emailed (SECURE) to CCTO-Safety@stanford.edu.
- PI signature on the SAE form is required for OnCore submission. CCTO-Regulatory will hold on entry of SAEs that do not have the PI signature, as the group cannot take action on medical information unless it is documented as the determination of the investigator. Secure digital signature on the PDF form is acceptable for submission to CCTO-Safety / CCTO-Regulatory.
SAE reports should be submitted to CCTO-Safety promptly, although there is no explicit due date. It is recommended that reports to CCTO-Safety should occur concurrent with the first notification to any other party of interest (industry collaborator, IRB, FDA, etc), which have explicit timeframes for reporting some or all SAEs.
Please ensure that all SAEs submitted to CCTO-Safety have been reviewed and signed by the investigator.