January 2023
- New! Non-Industry Fee Schedule / Site Budget Guidance
- Updated! UUSOP-14: Safety Assessment and Reporting has been updated with procedures for investigator review and assessment of laboratory and imaging reports, including the clinical significance of abnormal results (see section 2.7 of UUSOP-14).
- Updated! UUSOP-13: Institutional Fee Schedule andUUSOP-13-A: Fee Schedule Cost Rationale have been updated to include the addition of mandatory fees associated with participant payments.
The Non-Industry “Fee Schedule” / Site Budget Guidance Document provides a new resource to help researchers analyze costs associated with participating in non-industry funded clinical trials. Specifically, this document provides important guidance and strategies for creating a site cost budget, reviewing “non-negotiable” budget, analyzing site reimbursement method(s), managing routine care items, categorizing costs, and anticipating the types of expenses associated with participating in non-industry funded clinical trials. The Non-Industry “Fee Schedule” provides a starting point for budget analysis, meaning that not all the examples listed in the document apply to every protocol and that there may be other items in a specific clinical trial that represent a site cost.
Please note that for industry funded clinical trials, please refer to UUSOP-13 (Institutional Fee Schedule) and UUSOP-13-A (Cost Structure Rationale) for guidance and resources.