The timing and process for budgeting a clinical study will vary depending on the study’s funding source, and whether the budget is being negotiated with an Industry Sponsor or Clinical Research Organization (CRO) or submitted as part of a proposal for non-Industry grant funding. Regardless of funding source, there are resources available to help departments and study teams identify costs and ensure a clinical study budget complies with all applicable State and Federal regulations, as well as IU and IU Health policies.
For most Industry-funded clinical studies, the budget process begins when the Sponsor or CRO provides a proposed budget. The Sponsor’s first offer will not account for all the costs associated with conducting the study at IU or IU Health. The budget must be modified to include all site costs, and when applicable, should not be finalized before the OCR has completed the Coverage Analysis and Billing Review to identify which study-related costs must be paid by the study.
The Office of Clinical Research (OCR) provides information and resources to help study teams identify clinical research site costs and build and negotiate Industry-funded study budgets.
Once the budget has been developed, a contact in the Principal Investigator’s department will negotiate with the Sponsor or CRO until a budget is agreed upon. The final budget will then be incorporated into the research agreement before the contract is finalized.
Currently, the OCR does not offer centralized services for budget development and negotiation, however, budgets are reviewed by the OCR Financial Compliance team as part of the Coverage Analysis and Billing Review to ensure that the billing plan complies with applicable research billing compliance rules and regulations and aligns with other key study documents.
For questions, contact OCR Financial Compliance team at ocrfin@iu.edu.
When a clinical study is part of a grant proposal for non-industry funding, the budgeting process will look quite different. The budget must be developed at the proposal stage, often in response to a competitive funding opportunity with specific guidelines and limitations. On their website, the Office for Research Administration (ORA) provides information on proposal budgeting, such as institutional rates, budget restrictions and funding caps, and cost share requirements.
For questions about proposal submission, contact the ORA Proposal Team ora@iu.edu.
Additionally, Proposal Development Services (PDS) in the Office of Research Development (ORD) provides a wide range of pre-award services including budget and budget justification preparation support. Sample budget templates are also available for download here.
For questions about PDS, contact pdshelp@iu.edu.
For Cancer Center Trials (studies involving cancer patients):
For studies involving the Cancer Center’s Adult Clinical Trials Office (CTO), please reach out to cto-finance-l@list.iu.edu for support with the budgeting process.
For studies involving the Pediatric Hematology/Oncology/Stem Cell Clinical Research Team, please reach out to rileyphosresearchteam@iuhealth.org for support with the budgeting process.
Building and negotiating your budget is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.