Some sites establish mechanisms to roll over funds after a certain period of time to the principal investigator or their department. This can mean that a particular percentage is relegated to both the principal investigator and to the research department when funds remain. Accounting principles for research can be separated from other accounting departments, so please ascertain that there is compliance oversight for this process. If the goal is to generate residual funds by participating in clinical trials, the overall intent might be questioned. Sound accounting principles with transparency should be applied.

When there are variances in budgets, the clinical team, including the principal investigator, should make decisions as the study moves forward, not wait until study closure. Analyzing the study cost while forecasting potential deficits can help manage the revenue appropriately while being more compliant.

With careful coverage analysis and budgeting, a more detailed management of expenses will occur. The variability of a projected revenue loss reported consistently during the trial leads to better accuracy in the study completion from a finance perspective. This type of overall accounting and management of study funds leads to better compliance in the billing of routine costs to payers as well.

In starting a clinical research site, Elizabeth Weeks-Rowe outlined in 2018 that “[a]ppropriate funding is integral to starting and continuing the site momentum until new trials can sustain the effort. The investigational site founders must know the amount needed to start the site, and how long the funding will cover all costs until xxx deadline and the need to re-fund or re-evaluate the effort.”^[1] Her advice is excellent for not only new sites but established sites that are looking for the pot of gold. Take the time necessary to manage study accounts closely so you will know what lies at the end of the rainbow.