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Trial planning

Trial budget

Establishing a clinical trial budget requires careful consideration of various expenses associated with conducting a trial.

Creating a trial budget involves identifying costs and preparing and reviewing the budget.

A clinical trial budget is a detailed itemised budget that outlines the estimated costs associated with conducting a clinical trial. The budget covers all necessary expenses from trial planning and initiation to management and completion. Developing a comprehensive budget is critical for securing funding, optimising resource allocation and facilitating the successful execution of a trial.

Creating a clinical trial budget involves the following planning:

Identify and estimate cost categories

Identify all perceivable costs.
Estimate or obtain quotes, where possible.
Consider contingency and miscellaneous costs.

Prepare a budget spreadsheet

Use a spreadsheet tool such as Excel to calculate costs.
Break down costs into different categories, such as staffing costs or costs per participant. Create a line item for each cost.
Break the budget down year by year.

Review and finalise budget

Review the budget to ensure all costs are accounted for and are realistic.
Seek input from the organisation’s governance department, finance professionals and other experienced investigators.
Obtain quotes and approvals to finalise your budget.

Monitor budget

Continuously track expenses during the trial to ensure the budget is being adhered to.
Regularly compare actual expenses with the budgeted amounts. If there are any significant changes in amounts, investigate the reason why.
If there are changes in the trial requirements and unexpected costs, adjust your budget accordingly.

Project protocol Participant recruitment and consent

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