As clinical trials continue to become more complex, as do their associated budgets. Unfunded, yet essential, study activities are a longstanding problem for the sustainability of studies. Sites are regularly challenged with accurately estimating costs and negotiating their study budgets to assure those costs are covered, as well as keep their businesses financially sustainable. These types of invoiceables – often called “hidden costs” – are generally not accounted for in the study budgeting process, which can be detrimental to long-term site sustainability.
SCRS, in collaboration with many members of our community and the contributors listed below, has produced two resources for clinical research sites to address these challenges.
The Site Invoiceables Guide contains a detailed overview of common billable items that a site should consider when assessing costs associated with a clinical trial. The goal of the document is to provide clarity to the terminology of line item invoiceables that are not uncommon in budgets and should be considered if applicable. It does not indicate specifics such as when or how much to invoice.
The Invoiceables Calculation Spreadsheet helps calculate the items described in the Site Invoiceables Guide. Both resources are designed to help guide and provide insight into common costs for conducting clinical trials. While the Site Invoiceables Guide is available to everyone, the Invoiceables Calculation Spreadsheet is exclusively for SCRS members.
Both resources are designed to help guide and provide insight into common costs for conducting clinical trials but may not be applicable in every trial instance. Care should first be taken to understand your site’s individual cost for these items in the event they may be realized for a given study. SCRS does not guarantee that these items will be accepted within your final budget but feels strongly that these are realistic and reasonable costs for the sites conducting clinical trials. However, these resources will help provide a foundation for a more productive budgeting discussion to assure a study has enough resources to be successful for all stakeholders.
Site Invoiceables Guide
Understand key components of protocol budgets and how to appropriately plan for all associated costs. Please read the first section of this document prior to use in order to maximize its value and usage.
Thank You To Our Key Project Contributors
SCRS acknowledges and thanks the many others who also contributed to the content of this work through
conversations, online community discussions and industry meetings.
Elite Research Network
Clinical Site Partners
American Health Network
Vivienne van de Walle