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

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, 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:

Phone 202-687-8712
Fax 202-687-3111

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:

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.