Mastering Research Budgeting: A Guide to Using the Clinical Trial Budget Template

Creating an accurate budget for clinical research is one of the most critical and complex tasks in study planning. Whether you're an investigator launching a new study or a research coordinator managing multiple trials, having a comprehensive budgeting tool ensures you account for every cost and maintain financial viability.

This guide walks through the Clinical Trial Budget Template—a comprehensive Excel tool designed specifically for investigator-initiated research at institutions like the Murdoch Children's Research Institute.

What is a Clinical Trial Budget Template?

A clinical trial budget template helps researchers plan, track, and manage all costs associated with conducting a study. It accounts for procedures, laboratory tests, personnel time, pharmacy services, and infrastructure overhead, ensuring the study is properly funded from start to finish.

Key Features of This Excel Template

This comprehensive file consists of eight interconnected worksheets:

• Budget creation: The main worksheet for building your study budget by visit type
• Budget tracking Yr 1: Track actual income and expenses month by month
• Budget creation drop downs: Reference data for overhead percentages
• Budget - tips: Essential guidance on overhead, on-costs, and budgeting considerations
• Budget time & resources list: Build a database of procedure times and costs
• Budget P&L - printable: One-page profit and loss summary for department heads
• Summary: Compare your site budget against sponsor budgets
• Reference: Drop-down lists for consistent data entry

The template uses color-coded cells to indicate where you enter information versus automatic calculations.

How to Use the Template

Step 1: Enter Study and Set Up Visits

Enter your protocol details, participant numbers, and overhead percentage. The visit matrix across the top lets you map costs to each study visit type.

Start by entering your protocol name, version date, principal investigator, and department. The site is pre-set to Murdoch Children's Research Institute with an infrastructure overhead of 20 percent—confirm this applies to your funding source.

Set the number of participants and review the visit types across the top. The template includes screening, treatment, and follow-up visits—add or remove columns as needed for your protocol.

Step 2: Build Procedure and Personnel Costs

Work through each section row by row, entering unit costs for procedures, lab tests, and personnel time. The template automatically calculates subtotals per visit.

The budget is organized into four main sections:

• Procedures: List every assessment from your protocol schedule— informed consent, physical exams, vital signs, data management, and any specialty costs like neuropsychology or radiology. For staff time, you can either enter a direct cost or include it in the personnel section below.
• Laboratory Tests: Include haematology, serum chemistry, specimen collection and shipping, pregnancy tests, and any protocol-specific lab work.
• Personnel: Calculate staff time including base salary plus on-costs (25 percent for superannuation, workers' compensation, etc.). The template notes that full-time salary divided by 1976 hours gives an hourly rate.
• Pharmacy: Include drug dispensing fees and any other pharmacy-related costs.

As you enter unit costs, the template automatically calculates per-visit subtotals and accumulates them in the Total column.

Step 3: Add Additional Study-Wide Costs

Don't forget study-wide costs like statistical support, regulatory fees, archiving, and participant reimbursements. These are separate from per-visit costs.

Scroll to the bottom of the Budget creation sheet to find the Additional items section. Here you'll enter costs that aren't tied to individual participant visits, such as:

• Statistical review and analysis
• HREC and governance review fees
• eCTN fees to the TGA (required for most drug and device trials)
• Archiving and document storage
• Pathology and pharmacy establishment fees
• Staff travel for home visits
• Participant travel reimbursement and meal allowances

For each item, enter the unit cost and number of units. The template calculates the total including overhead.

Step 4: Track Actuals Monthly

Use the tracking sheet to monitor actual income and expenses month by month. Compare against your projections to catch variances early.

Once your study is underway, switch to the Budget tracking Yr 1 sheet. This worksheet lets you record:

• Total income received each month
• Per-patient costs as they occur
• Salaries and wages paid
• Invoices processed
• Additional expenses

The sheet calculates monthly balances and projected cumulative end-of-month balance, helping you stay on top of your study finances.

Understanding Key Concepts

• Overhead Infrastructure Fee: The template applies a 20 percent overhead to most income sources. However, this fee is not charged for NHMRC grants, other competitive peer-reviewed grants, or donations. Check with your finance department if unsure.
• On-costs: These are supplementary costs of employment including workers' compensation, leave loading, superannuation, and payroll tax. The template uses 25 percent—confirm this rate for your institution.
• Per-visit vs. Study-wide Costs: Some costs happen once per participant visit, while others are one-time or annual expenses. The template separates these clearly to ensure nothing is missed.

Building Your Time and Resources Database

Build a customized database of procedure times and costs. Over time, this becomes an invaluable reference for creating future budgets faster and more accurately.

The budget time & resources list sheet is a powerful feature that lets you document the time required for every study activity. As you complete more studies, this list grows into a personalized reference that makes future budgeting faster and more defensible when justifying costs to sponsors.

Categories include concept development, set-up fees, HREC submissions, recruitment, pharmacy, pathology, radiology, safety monitoring, patient costs, and more.

Printable Profit and Loss Summary

This one-page summary is perfect for department heads and finance committees. It shows total income, expenses, and net margin at a glance.

The Budget P&L - printable sheet distills your entire budget into a single page. It includes:

• Study identification and duration
• Budgeted income from funder
• Budgeted per-patient and additional expenses
• Net margin (profit or loss)

This is particularly valuable for investigator-initiated studies where departments may need to support research. It provides clear accountability for decision-making.

Tips for Success

1. Base the budget on the protocol schedule of assessments. Work through each line item systematically to ensure nothing is missed.
2. Establish early which supporting departments are needed. Contact radiology, pathology, pharmacy, and others to obtain accurate costings before finalizing your budget.
3. Include sub-studies. If your protocol includes additional studies, ensure they have their own budget lines.
4. Estimate labour time accurately. Use available salary scales and include on-costs. Consider charging a fee for commercially-sponsored research.
5. Track money in and costs out at least quarterly. Regular tracking prevents surprises and allows course correction.
6. Build your own lists of standard times. Use the time and resources sheet to document everything. Each budget becomes easier than the last.

Frequently Asked Questions

What overhead rate should I use?
MCRI applies 20 percent to most income sources except NHMRC grants, other competitive peer-reviewed grants, and donations. Check with your finance department for your specific situation.

How do I calculate hourly rates for staff?
Divide full-time annual salary including on-costs by 1976 hours (52 weeks × 38 hours). This gives you an accurate hourly rate for budgeting.

What if my study has more visits than the template shows?
The template includes nine visit columns. You can continue adding more visits as required by your protocol—the instructions note "Continue with as many visits as required per protocol."

How do I handle screen failures?
Consider including screen failures in your participant number estimate or adding a line item in additional costs. Screen failures still consume staff time and resources.

Can I use this for commercially-sponsored research?
The template was developed for investigator-initiated research. Contact your institution for guidance on budgeting for commercially-sponsored studies.

Conclusion

Clinical trial budgeting is complex, but the right template makes it manageable. This comprehensive tool guides you through every step—from building per-visit costs to tracking monthly actuals to presenting a one-page summary to department heads.

Download the template, study the examples, and start building your budget section by section. The time invested in accurate budgeting pays off throughout your study's life.