New Trial Start-Up

Three GU offices are involved in the approval of any new clinical trial. :

IRB- Institutional Review Board Office
- Room SW104, Med-Dent Bldg
- 202-687-0328
OSR- Office of Sponsored Research
- Room 1100, 3300 Whitehaven Street, NW
- 202-687-1701
CTO - Clinical Trials Office
- 255 Basic Science Building
- gucto@georgetown.edu

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 approved by the University. Please forward all CDA's to Sharon Prisco, MS, JD at:
- Phone 202-687-8712
- Fax 202-687-3111
- Email sep39@georgetown.edu

After receipt of the signed confidentiality agreement, the sponsor should supply you with the:

You should fill out/complete the:

Informed consent form (ICF). You will need to merge the information provided in the sponsor supplied ICF into the Georgetown ICF template
IRB on-line application. 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").
PACTS on-line contract/budget submission application. You can access PACTS at https://georgetown.interneer.com/intellect. Please contact Tony Hursey at tlh3@georgetown.edu if you need a user account for the system. Note that the current version of PACTS has incorporated the information previously contained in the paper transmittal form and is no longer needed.