The Office of Clinical Trial Activation provides tools and resources to help study teams develop study budgets when OCTA is not preparing the full study budget, such as for non-profit studies, grant-funded studies, financial feasibility, or budgets developed by the study department.
Use the steps and resources below to identify and budget for research administrative fees, study personnel effort, patient care costs, research recharge services, and other study-related expenses.
Industry-sponsored studies: If OCTA is preparing your budget, visit OCTA Budgeting Services for information about OCTA’s budgeting and negotiation process rather than using these resources to develop the budget independently.
How to Build Your Study Budget
STEP 1: Identify protocol-required items and services
Non-Profit / Government Funding:
• Review the protocol with the study team/PI to identify study-required procedures.
• For funding proposals, a Coverage Analysis is not required. If funding is awarded, use the Coverage Analysis Determination Form to determine whether a Coverage Analysis is required.
Industry / Non-Government Funding:
• Use the Coverage Analysis Determination Form to determine whether a Coverage Analysis is required.
• If a finalized Coverage Analysis is available, identify protocol-required items and services designated R = bill to sponsor.
STEP 2: Identify other research fees and study costs
In addition to protocol-required items and services, identify other costs associated with conducting the study. Use this resource to identify common clinical trial budget categories, how to budget them, and find pricing and billing details.
Research Fees & Items to Budget
STEP 3: Determine how to price each item or service
Use the table below to determine which budgeting or pricing resource to use. Examples are illustrative and are not an exhaustive list.
| What are you budgeting? | Examples | How to budget |
| Research Administrative Fees and other study costs | IRB initial review, clinical research billing compliance new study or amendment, investigational drug services pharmacy set-up, participant payment/reimbursement, study document translation | Use Research Fees & Items to Budget to identify applicable costs and determine how they are billed and/or priced. |
| Study Personnel Effort | Participant questionnaires, medical chart reviews, collecting AE/SAE or concomitant medication data, follow-up phone calls, research data collection from procedures occurring as part of regular clinical care | Use Study Personnel Effort Recommendations to estimate study personnel effort. |
| Research Recharge Services | CTSI Nursing services for participant study visits, Radiology services | Use Research Fees & Items to Budget to identify applicable research recharge services and how they are billed and/or priced. |
| Clinical Items/Services | Physical exam, laboratory assessment, ECG, Imaging (e.g., CT, MRI, PET), administration of investigational item(s) involving a single CPT code | Use the Research Fee Schedule to obtain applicable hospital billing (HB) and professional billing (PB) rates. |
| Complex Clinical Items/Services | Biopsy, lumbar puncture, administration of investigational item(s) involving multiple CPT codes, procedures involving the OR, anesthesia, specialty/treatment or recovery room/PACU, or when pricing isn’t available in the research fee schedule | Submit a Procedural Pricing Request Form to obtain a pricing estimate. |
STEP 4: Add costs to the study budget
Add all identified study costs to the budget, including applicable research administrative fees, study personnel effort, research recharge services, patient care costs, and other study-related expenses. Apply the appropriate indirect cost rate, as applicable.
Indirect Cost Rates
• Industry-Sponsored Projects
• Non-Profit/Government Projects