Setting Up Your Award

Take some time to think about what committing to a trial for a particular drug or device will mean to you as a scientist and a person:

• Do you agree with the mission?
• Is the study feasible?
• Will the protocol advance scientific knowledge?

Remember, the integrity and medical value of the research must be top of mind.  

We have established safeguards to protect you, your work and our institution. Our teams will guide you every step of the way. Please note that all agreements will be made on behalf of Rush University. 

Here are the steps you'll need to complete before beginning an industry sponsored clinical trial. 

1. Confidential disclosure agreement: The industry sponsor of a clinical trial may need to share proprietary information with you, even early on so you can decide whether to participate. In that case, the sponsor may send you a confidentiality disclosure agreement (CDA). To protect both Rush’s interests and yours, the Office of Legal Affairs team will negotiate the CDA. These agreements can only be made between the sponsor and the institution.
2. Coverage analysis: The Research Revenue Cycle team will create a billing system consistent with our policies on clinical trial billing compliance. Coverage analysis identifies who should be billed for each patient care item or service delivered during a clinical trial: the study sponsor or the research subject’s insurer.
3. Study budget development: Industry sponsored clinical trials require expert budget development. The members of our Clinical Research Finance team understand budget terminology, concepts, and payment terms and schedules. They will also accurately capture Rush’s institutional and departmental research costs. We will share tools, templates and training, too; take a look at our budget education manual through the Rush Research Portal. For more information, contact Kelli Jones, MSN, CCRC, educator, kelli_jones@rush.edu; or Priya Mishra, PhD, clinical research liaison, priya_mishra@rush.edu.  
   
   Learn more: Clinical Trial Budget Considerations
4. Contract negotiation: The Office of Legal Affairs will negotiate the legal terms of the contract with study sponsors on behalf of Rush University and obtain the appropriate signatures. For more information, contact Erin Blackmon, JD, contracts and research counsel, erin_blackmon@rush.edu.  
5. IRB review: If your research involves human subjects or is regulated by the FDA, it will require review and approval from our Institutional Review Board, part of the ORA. That resource can help you determine if your protocol will need a full, expedited or exempt IRB review.
   
   Learn more: Types of Institutional Review Board review
6. Sponsor invoicing: The Sponsor Invoicing team creates invoicing grids for data collection on study participants and procedures that align with the approved budget. Sponsor invoicing allows for the accurate reconciliation and receivables of study costs.
7. Synchronization: The Clinical Research SYNC team will perform an internal review of all study documents prior to institutional endorsement to ensure that informed consent agreements for research subjects are consistent with the coverage analysis, your budget and the contract with the study sponsor.
8. Account setup: Once a clinical trial agreement is finalized with the industry sponsor, an email will go out from the research portal to the Office of Corporate Finance, Fund Accounting, triggering the setup of your research study account.

An industry sponsored clinical trial agreement is a contract. A researcher must fulfill the terms, even if the actual costs exceed the agreed-on compensation, so your front-end estimate needs to predict as closely as possible your total outlay for the trial.

Calculate your costs 

Make a sample budget. You can consult our Budget Education Manual, geared toward industry sponsored trials, through the Rush Research Portal.  

We can help

Our teams will help you keep your budget real every step of the way. The Office of Research Affairs supports investigators in the following ways: 

• Budget development and negotiation of clinical trial agreements with sponsors 
• Study initiation, patient recruitment and follow-up 

Clinical Research Administration

Linda Bond, MSN, BSN, CNP
Associate Vice President, Clinical Research and Regulatory Operations
Phone: (312) 563-2780
Email: linda_bond@rush.edu

Research Revenue Cycle

Tralissa (Lisa) Morrow
Director, Clinical Trials Research Revenue Cycle
Phone: (312) 563-2742
Email: tralissa_morrow@rush.edu