Table 2.

Criteria for immediate reporting of serious adverse events.*

Serious**and Unexpected and Related to the Study Therapy
Serious**
Institutional Review Board   Office of Biotechnology Activities/Recombinant DNA Advisory Committee  
Institutional Biosafety Committee   
Federal Drug Administration   
Corporate Partners   
Serious**and Unexpected and Related to the Study Therapy
Serious**
Institutional Review Board   Office of Biotechnology Activities/Recombinant DNA Advisory Committee  
Institutional Biosafety Committee   
Federal Drug Administration   
Corporate Partners   
*

All serious adverse events are reported in the annual Investigational New Drug (IND) report.

**

Serious defined in text.

View Large
This Feature Is Available To Subscribers Only

or Create an Account

Close Modal
Close Modal