The Research Business Services (RBS) team supports the Aurora Research Institute by ensuring a consistent application of general Research business practices. Acting as a resource in matters of contracting, budgeting, planning, monitoring, reporting, compliance, and operations, the team provides oversight and direction to Aurora Research Institute caregivers.
Contract Services - RBS supports clinical trials by providing contract review, negotiation and oversight for all Industry sponsored research projects conducted at Aurora Health Care.
Contract services include:
- Confidentiality agreement/non-disclosure agreement review and negotiations.
- Contract review.
- Risk analysis.
- Contract negotiation and drafting.
- Legal and regulatory compliance review.
- Protecting research subject privacy.
- Physician Investigator agreements review.
Contract budgeting - RBS provides protocol review, budget preparation, CPT code selection, negotiation and oversight for all industry-sponsored research projects conducted at Aurora Health Care.
Budget services include:
- Study protocol review.
- Budget preparation.
- CPT code selection.
- Pricing of protocol required procedures.
- Ensuring Medicare billing compliance - Clinical Trial Coverage Analysis (CTCA)
- Budget negotiation
Policies and templates
- Subject Injury Policy.
- IRB Fee Policy.
- Study Feasibility.
I want to open a new study. Who do I send the documents to?
- Documents need to be sent to RBS at firstname.lastname@example.org.
What documents do I need to send when I want to open a new study?
- RBS needs the RBS Document Request Form, the official site selection letter from the sponsor, the current protocol, applicable Food and Drug Administration (FDA) documentation, sample informed consent, sponsor proposed budget and contract, and any other documents sponsor may have sent.
What happens once I send the documents to RBS?
- RBS will log the study into the work queue as RBS operates in a first-in first-out manner. When RBS begins work on a new study, RBS will assign a RBS Budget Specialist and an RBS Contract Specialist to the study. You will be notified of your contacts once RBS begins work. RBS will also notify the sponsor at that time. RBS may contact you throughout the budget and coverage analysis process with additional questions. It is important that questions are answered in a timely manner so that the process can be finished in the planned timeframe.
Who do I contact if I have questions regarding my budget?
- Questions should be directed toward the RBS Budget Specialist who has been assigned to your study.
Who do I contact about my contract?
- Questions should be directed toward the RBS Contact Specialist who has been assigned to your study.
- Who do I contact for general questions or information?
- Grant Services
- Internal Funding
- Post Award Monitoring
- Revenue Cycle and Operational Cycle Oversight
- Financial Activity Facilitation
- Budget Planning
- Financial Planning, Monitoring and Reporting