An Investigator Must Submit the Following Items to the Clinical Trials Office (CTO) for Each New Industry-Sponsored or Industry-Supported Study:  

e-OGM1 form

Clinical Trial Worksheet*

3 copies of the approved budget* (including 30% indirect costs for all studies and $1,500 IRB fee for industry-sponsored studies)

3 copies of the protocol

1 copy of the FDA form 1572 submitted to sponsor

letter addressing relationship with sponsor, if applicable*

electronic copy of the clinical trial agreement draft, if one has been provided* 

*These documents must be attached to the e-OGM1, or CTO will reject the form.  Please use the "attachment" button (located at the bottom of the form) to attach the documents to the form. 

You may access the Clinical Trial Worksheet and the eOGM1 form by using the link below:  

ERGO

If you have any questions about the Clinical Trials Worksheet, eOGM, or ERGO please contact the Research Administration Helpdesk @ 214-648-5006