We are excited to share an upcoming change in budget services provided by Office of Clinical Trial Activation (OCTA).
Beginning September 1, 2026, the Industry Contracts Division (ICD) within the Office of Sponsored Research and the Office of Clinical Trial Activation (OCTA) will launch a pilot for budget services for certain industry-sponsored studies that do not fall under Clinical Research Billing (CRB) requirements. Non-CRB studies do not require Coverage Analysis and do not generate charges in APeX, UCSF’s electronic Epic-based, Medical Record System. Under the pilot, OCTA will provide budget development and negotiation services for eligible studies, while ICD will continue to provide agreement review, negotiation, and execution. The pilot will allow ICD and OCTA to evaluate the new service model, including the study intake and referral process, and identify adjustments as needed.
Studies included in the pilot are:
- Industry-sponsored studies with non-CRB budgets where industry is the primary funding source and UCSF is conducting research involving UCSF/ZSFG/VAMC patients, patient data or human biospecimens.
The pilot is intended for non-CRB study budgets and does not apply solely because a project involves the transfer or provision of UCSF patient data or specimens.
What does this mean for you?
For applicable industry-sponsored studies, study teams should continue to start with the Coverage Analysis Determination Form (CADF), to determine whether the study requires a Coverage Analysis. The determination will provide instructions regarding appropriate next steps. If a potentially eligible study is submitted directly to ICD, ICD will review the study to determine whether it falls within the pilot and direct you to OCTA for budget services when applicable. During the pilot, ICD will remain the study team's point of contact for agreement review, negotiation, and execution.
What is not included?
The following studies are outside the scope of the pilot and should follow existing budgeting processes:
- Animal research
- Studies conducted exclusively outside the United States
- Studies for which UCSF serves solely as the coordinating center and no UCSF/ZSFG/VAMC patients, patient data, or specimens are involved
- Chart-review/data-only studies where the industry sponsor provides the data
- PI consulting agreements with no UCSF patients, patient data, or specimens
- Budget development or negotiation already underway within ICD before the pilot launch
During the pilot, ICD and OCTA will work closely together to support continuity of service, evaluate the pilot process and make adjustments as needed.
For questions, please contact: [email protected] or [email protected]
When OCTA Provides Budgeting Services (pilot changes highlighted in red)
