What Goes Into a Clinical Trial Budget: 8 Cost Components Explained

Tufts CSDD has reported average Phase III budgets above $65 million for oncology protocols and $54 million for non-oncology protocols (Tufts CSDD Impact Report, 2022). That total is built from two kinds of budget: the sponsor's study budget, covering everything needed to run the trial, and a site budget for each research site, covering the work done there.

This explainer focuses on the site budget, where most negotiation and most payment questions happen. Here are the eight components you will find in almost every one.

Study budget versus site budget

1. Per-visit and per-procedure fees

The core of a site budget. Each visit in the protocol's schedule of assessments has a fee, built from the procedures done at that visit, such as physical exams, labs, ECGs and questionnaires, plus staff time. Sites are paid as participants complete visits.

2. Screen failure fees

Participants who are screened but do not qualify still take staff time and procedures. Budgets usually pay for screen failures, often up to a set ratio of screen failures to enrolled participants.

3. Start-up and administrative fees

One-time fees that cover the work of preparing a site: contract and budget negotiation, regulatory documents, training and site initiation. They are often paid when the site is activated.

4. Ethics or IRB fees

The cost of ethics review for the site, including initial review and continuing review or amendments, where the site pays for it.

5. Pass-through costs

Costs the site pays on the sponsor's behalf and invoices back, such as participant travel and reimbursements, local lab tests, imaging or equipment. They are paid on actual cost, so they are invoiced separately and checked against the budget.

6. Institutional overhead

Also called indirect costs. Many institutions add a percentage to cover facilities and administration. Whether it applies to all fees or only some is agreed in the contract.

7. Close-out and archiving fees

Fees for close-out visit work, final queries and long-term storage of the investigator site file, which must be kept for years after the trial ends.

8. Payment terms and holdbacks

Not a cost, but part of every budget. Payment terms set how often and how quickly the site is paid, and a holdback keeps back a share of payments until close-out. Terms of up to 90 days from a correct invoice, sometimes with holdbacks, are common (Applied Clinical Trials).

Site budget checklist

• Visit fees built from the schedule of assessments
• Screen failure fees and the ratio they apply to
• Start-up, IRB and close-out fees listed separately
• Pass-through costs listed, with how they will be invoiced
• Overhead rate and which fees it applies to
• Payment frequency, terms and holdback percentage
• How amendments will change the budget

What this means by role

• New clinical operations and study start-up staff: these eight components are the vocabulary of every budget negotiation.
• Study finance teams: keeping components separate makes payments, forecasting and reconciliation easier.
• CRCs and site finance teams: knowing the components helps you check that every cost of the study is covered.

How Cloudbyz helps

Cloudbyz Clinical Trial Financial Management (CTFM), built natively on Salesforce, holds study and site budgets with these components, built from templates, rate cards and the study visit plan. Completed visits generate invoices against the site budget, with payment terms and holdbacks applied per contract.

See how Cloudbyz CTFM works or visit cloudbyz.com.