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Clinical Trials Resource Group

Clinical Trials Resource Group

Number3IND/IDE Process: Submit to IRB

For Content and Format of IRB submissions, please see,1,2018 . If after reviewing your submission the IRB still has regulatory concerns, the PI may have to correspond with the FDA to obtain a formal determination of IND exemption or NSR designation. 

To file the IDE, go to  IDE Step 4 

To file the IND, got to IND Step 4 

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