An investigator must submit the following items to the Clinical Trials Office (CTO) for each new industry-sponsored or industry-supported study:  

e-OGM1 (CTO) form

Clinical Trial Worksheet (Include an attached list of the names of all Study Personnel and electronic copies of GCP Training certificates for each person named on the list)

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

3 copies of the protocol (Double-sided is allowed)

1 copy of the signed FDA form 1572 as 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 ERGO link here: ERGO

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