CROO

How You Use the Clinical Research Operations Office

For any new study, the CROO will manage the following inter-related processes:

• External Budget Negotiation
• Research Billing Plan and Cost Analysis
• Internal Budget Development
• Sponsor Invoicing – for commercial clinical trials

The external budget is typically an attachment to the clinical trial contract (or CTA) for your trial. 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 CROO handles these negotiations for you.

The research billing plan is the result of collaboration between the PI, SC, and the CROO.  It requires documenting all tests and services involved in the study, and clearly identifying who (the grant, insurance, the participant) pays for each and every service.

The cost analysis: CROO performs a cost analysis of your new study in order to insure that you are being offered funds which are adequate to cover the cost of conducting your trial at Georgetown.  The CROO uses the cost analysis to negotiate the external budget with your sponsor.

The internal budget The CROO creates an internal budget which describes in detail how your study funds will be allocated internally.  No CTA can be fully executed without an internal budget signed off by the PI, home department, BGRO, and MedStar (for the hospital services section)

The CROO 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

What you need to do:

• Submit your sponsor supplied documents (including the external budget) to the PACTS system.  
• Work with the CROO budget analyst to complete a research billing plan, cost analysis, and internal budget.