Page 449 - eBook Version 8 Book 1 of 2 JUL 2022
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Levels of Reporting July 24, 2020
Reporting: Institution CHST
Research Reporting: All serious and unexpected adverse events that are likely or possibly related to a research
study as determined by the Principal Investigator (PI) and occurring on a CHST campus will be reported within five working days to the following email address: researchadverseevent@childrens.com.
1. Report to IRB ( ≤ 5 days of discovery)
2. SafeLink ( ≤ 24 hours of discovery)
3. Sponsor (if applicable) ( ≤ 24 hours of discovery)
4. ForprincipalInvestigators(PI)whopersonallyhaveanINDorIDE:follow21CFR312.32or812subpartE
(Same day as discovery)
5. Team Lead, Director, & Senior Director (same day as discovery)
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