Accurate calculation of patient visit costs at investigative sites is one of the key elements of clinical trial budgeting — and one of the most challenging. Errors at this stage often lead to site renegotiations, start-up delays, and, during the trial, uncontrolled cost increases. To ensure reliability, the budget should follow a “per visit / per procedure” approach and clearly distinguish between fixed and variable costs.
The starting point is the Schedule of Assessments (or Data Collection Overview), which outlines all procedures performed at each visit. For every visit, three primary cost components should be identified:
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medical and diagnostic procedures (e.g., ECG, imaging, specialized assessments),
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laboratory tests (routine and specialized, including sample collection, processing, and logistics),
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site staff time (principal investigator, sub-investigator, study coordinator, nurse, pharmacist, laboratory personnel, administrative staff).
In practice, the most secure methodology is to calculate costs based on unit rates and time allocation. First, determine which elements are reimbursed as specific procedures (fee-for-service) and which are time-based. For staff time, hourly rates should be defined for each role, along with realistic estimates of the time required for visit preparation, performing procedures, source documentation, eCRF entry, safety reporting (including AE/SAE), and query management or data corrections. A frequent oversight is the failure to account for “invisible time” — tasks that are not immediately apparent but cumulatively create a significant workload for the site.
The next step is to separate costs that are not strictly visit-related but have a substantial impact on the overall budget. These include start-up activities (training, site activation, regulatory documentation), screen failures, re-screening, unscheduled visits, pharmacy and IMP handling, archiving, as well as quality-related activities such as monitoring, corrections, and query responses. A best practice is to define clear payment rules: which costs are payable only upon patient enrollment, which upon visit completion, and which are paid independently (e.g., start-up fees).
To minimize budget discrepancies, the proposed budget should be validated against site-specific realities: availability of procedures, local pricing standards, patient management pathways, and staff workload. The most effective approach combines standardized calculation methodology with full transparency, facilitating constructive negotiations with sites and reducing the likelihood of mid-study budget amendments.
If you want to build a patient visit budget that is predictable and acceptable to study sites, contact us — we will help you prepare a calculation based on real procedures, actual staff time, and practical reimbursement standards, minimizing the risk of costly changes during the project.
