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, click here to 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 at https://eric.ora.georgetown.edu/eric. First time users need to click on "registration" to receive an activated account ("user role").
- Submission of CTA and budget using PACTS. You can access PACTS at https://georgetown.interneer.com/intellect.
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.