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Modification to OnCore entry of Serious Adverse Events (SAEs) for Industry Sponsored trials

November 21, 2019 - SCI Communications

Beginning on 25th Nov 2019, CCTO will no longer enter Serious Adverse Events (SAEs) for Industry sponsored trials into OnCore; sending completed SAE form to CCTO-Safety for Industry sponsored trials is no longer required starting November 25th, 2019.

As we are aware, this requires an update to our SOP and guideline documents. The modifications to these documents are in process and they will be shared as soon as they are updated. 

In the meantime, a memo on this decision is posted on the CCTO Regulatory page under Reporting Internal Serious Adverse Events section.

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