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
202-687-0328

OSR - Office of Sponsored Research

Room 1100, 3300 Whitehaven Street, NW
202-687-1701

CTO - Clinical Trials Office

Suite 603, 2115 Wisconsin Avenue, NW
gucto@georgetown.edu

Step 1

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:

Phone 202-687-8712
Fax 202-687-3111
Email sep39@georgetown.edu 

Step 2

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)
Step 3

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.  
Step 4

Consider any other additional departments that you might need to work with in starting up your study

Step 5

Check out the final checklist before you begin.