The Office of Clinical Research (OCR) helps teams manage clinical research finances from start to finish. Before funding is awarded (pre-award), our team will help you determine Medicaid/Medicare coverage, analyze the study cost and timeline, negotiate budgets with study sponsors, and enter budget information into the university’s new clinical trial management system, OnCore. After funding is awarded (post-award), we will help with invoicing, revenue reconciliation, review of patient’s accounts, and more.
There are fees associated with our pre-award, post-award and research billing review services. Please email OCR_Finance@URMC.Rochester.edu for more information about service fees.
- Create a minimal protocol shell in OnCore, which your team must complete using the minimum footprint
- Create a study calendar in OnCore, which your team must validate
- Create study budget in OnCore
- Negotiate budget with study sponsor, working closely with you
- ORPA negotiates the language of the clinical trial agreement, we negotiate the part of the agreement that speaks to the study budget.
- Work with Research Compliance to get your study approved, after which your team will need go through the ORPA process for signatures.
Post Award Services
- Invoice the study sponsor
- Track payments and link them back to the invoice in OnCore
- Follow up on invoices
Your team will need to reconcile your account and file any HRMS forms for staff.
Research Billing Review
- Research billing review for each patient over the life of study
- Reviewing patient information in eRecord, approve study charges.
- At your request, we can also review monthly statements and process them for you
The Office of Clinical Research is committed to helping study teams obtain reimbursement for their study-related costs. We are available to consult on strategies to get the costs covered, including providing the sponsor with a memo stating our costs.
If you would like a memo on any of the topics below, please email Clinical_Research@URMC.Rochester.edu.
- Monitoring Visits Reimbursement
- Document Storage and Archiving
- Dry Ice
- Recruitment of Subjects
- Screen Failures Ratios
- Start Up Cost
- Use of CTMS for standard costs