New Trial Start-Up

What offices do I need to work with to get my trial approved for enrollment?

Three Georgetown University offices are involved in the approval of your clinical trial:

• IRB - Institutional Review Board Office, Room SW104, Med-Dent Bldg
• OSR- Office of Sponsored Research, Room 1100, 3300 Whitehaven Street, NW
• CTO - Clinical Trials Office, 7 Main Hospital Building, Room M7500

What do each of these offices need from me?

Step 1
Your first contact with a study sponsor about a new trial typically involves a request by the sponsor that you fill out a Site Information Sheet. For help with information typically required for the Site Information Sheet, click here. Once chosen as a site, the principal investigator (PI) is asked to sign a confidentiality agreement. This document does not need to be reviewed or approved by OSR, but should be read carefully by the PI before it is signed.

Step 2
After receipt of the signed confidentiality agreement, the sponsor should supply you with:

1. A copy of the study protocol
2. A draft of the Clinical Trial Agreement (CTA)
3. A draft of the budget for the study (often an attachment to the CTA)

Step 3
You should:

1. Review the protocol and begin:
   1. filling out the IRB application (IRB involved)
   2. developing your informed consent
2. Fill out a Transmittal sheet and forward (along with a copy of the study protocol) to your department chairman for signature. The Transmittal sheet is required by OSR in order to complete execution of your study contract.

Step 4

1. Forward the draft of the CTA to OSR and supply the study sponsor with contact information for OSR. (OSR involved)
2. Forward the draft budget and a copy of the protocol to the CTO to begin work on the budget for your study. (CTO involved)

Step 5
What additional departments might I work with?

Step 6
Check out the final checklist before you begin.