New Trial Start-Up: How You Use the Clinical Trials Office

One of the functions of the CTO is to help you with the budget for your new clinical trial. The budget which is typically an attachment to the clinical trial contract (or CTA) for your trial is referred to as an external budget. It describes how much money the sponsor is paying you per patient, what one-time or "pass through" fees are being paid to you, and what indirect or administrative overhead rate the sponsor is paying.

The CTO performs a cost analysis of your new study in order to insure that your are being offered funds which are adequate to cover the cost of conducting your trial at Georgetown.

After completing the cost analysis of the trial, the CTO can negotiate with your study sponsor if the external budget provided by the sponsor needs to be modified in any way.

The CTO then creates an internal budget which is required for all clinical trials. This budget describes in detail how your study funds will be allocated.

The CTO is your resource for up-to-date information (approved by MedStar) regarding current research rates for:

• Tests and procedures performed in the hospital
• Professional fees for trial related services
• Laboratory costs
• Special outside services

Please provide the CTO with a copy of your study protocol and any budgetary information given to you by the sponsor of the new study. Forward this information to us as early as possible in the Approval Process Flowchart.

The CTO charges a one-time fee of $1100 for all industry and physician-initiated clinical trials

CTO Contact Information