New Trial Startup
Three GU offices are involved in the approval of any new clinical trial:
IRB – Institutional Review Board Office
Room SW104, Med-Dent Bldg
OSR – Office of Sponsored Research
Room 1100, 3300 Whitehaven Street, NW
CROO – Clinical Research Operations Office
Room NW 213, MedDent Building
First contact with a study sponsor about a new trial typically involves a request for a:
- Site Information Sheet. For help with information typically required for the Site Information Sheet, please download a help sheet.
- CDA or NDA. Confidential Disclosure or Non-Disclosure Agreements. Please note that these agreements must be reviewed and signed by the University. Please forward all CDA’s to Sharon Prisco, MS, JD at:
After receipt of the signed confidentiality agreement, the sponsor should supply you with the:
- Study protocol and investigator brochure (IB)
- Clinical Trial Agreement (CTA)
- Study Budget (often an attachment to the CTA)
You should complete the following steps:
- IRB application using eRIC. The eRIC system can be accessed here .
users need to click on “registration” to receive an activated account (“user role”). Firsttime
- Submission of CTA and budget using PACTS. You can access PACTS here.
Consider any other additional departments that you might need to work with in starting up your study
Check out the final checklist before you begin.