Industry Sponsored Clinical Trials

Rush University researchers often oversee trials of drugs or medical devices that have been developed by private pharmaceutical firms or other businesses, as those firms seek to fulfill the regulations of the U.S. Food and Drug Administration (FDA) in bringing their products to market. 

These collaborations often begin when a firm approaches you directly, or the University may make the introduction. Our Clinical Research Administration, a division of the Office of Research Affairs (ORA), can help you identify potential industry sponsors, facilitate connections and set up a research study based on an industry sponsored agreement.  
 


Getting started

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

1. Confidential disclosure agreement
If the sponsor requests confidentiality, our team will negotiate and agreement that protects your interests. 


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
Our team identifies the correct party to bill for each trial need and creates a consistent billing system.


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
Our team provides tools to help you navigate budgeting—from terminology to payment terms.

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.  


4. Contract negotiation
Our team negotiates legal terms with study sponsors.


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
Our team helps determine the type of IRB review required, if any.


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.


6. Sponsor invoicing
Our team helps ensure accurate invoicing and reconciliation.


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
Our team helps ensure that the right informed consent agreements are in place.


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
Our team will initiate your research study account once everything’s in place.


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.

Contact Us

Linda Bond, MSN, CNP, associate vice president of clinical trials and regulatory operations
linda_bond@rush.edu

Priya Mishra, PhD, clinical research liaison
priya_mishra@rush.edu