Dear Research Community,
Effective July 1, the Office of Clinical Trial Activation will implement an updated fee structure for industry-sponsored clinical trials to reflect the increasing complexity of sponsor-funded trials, align with industry standards, and support the infrastructure needed for compliant and efficient clinical research operations. The fees have been endorsed by UCSF’s Clinical Trialist Advisory Committee (CTAC).
What is Changing?
1. Technology Fee
A Technology Fee will apply to new industry-sponsored studies and applicable protocol amendments. This fee supports the enterprise systems required for study activation, management, and compliant billing.
2. Clinical Research Billing Compliance Fee Adjustment
The Clinical Research Billing Compliance fee for new industry-sponsored studies will increase by 5%, from $2,800 to $2,940—its first adjustment since 2013—to reflect inflation and increased operational demands.
The Clinical Research Billing Compliance fee for applicable protocol amendments will increase from $1,000 to $1,050.
Why These Changes Are Necessary?
Sponsor-funded trials have grown significantly in complexity over the past decade, requiring sustained investment in infrastructure supporting:
• Coverage analysis and compliant billing
• Clinical trial management systems (e.g., OnCore)
• Regulatory and data platforms (e.g., eRegulatory, eSource + EDC)
• Cross-functional coordination across clinical, financial, and compliance workflows
Historically, UCSF has absorbed many of these operational and technology costs. This is no longer sustainable at the current scale and complexity of industry-sponsored research. These updates ensure UCSF can continue to:
• Deliver compliant, high-quality trial execution
• Reduce activation timelines and operational inefficiencies
• Mitigate financial and regulatory risk
• Maintain infrastructure aligned with sponsor expectations and industry standards
Impact for Sponsors and Study Teams
These changes:
• Align with industry standards for infrastructure cost recovery
• Support more efficient workflows and fewer delays
• Strengthen data integrity, billing compliance, and audit readiness
• Sustain UCSF’s position as a high-performing clinical trial site
• OCTA Budget Analysts will incorporate these updates into industry-sponsored clinical trial budget negotiations using standardized messaging.
Questions?
• See the OCTA Fee Memo reflecting the FY27 rates
• Please contact [email protected]