Start-Up
How to Start Your Research Study

The Office of Clinical Research (OCR) provides support for the start-up of clinical research activities at UCSF.  Leadership at UCSF has recognized the important relationship between campus and UCSF Health Systems in the conduct of clinical research, and the OCR helps to synergize operations between the two entities.

In starting your research review the Office of Clinical Research (OCR) website for information on coverage analysis and budgeting. At UCSF we use a formal Coverage Analysis (CA) process to ensure compliant clinical research billing.  A CA is necessary for all clinical trials involving interventions in which any items and services are or may be invoiced to the patient insurer(s). Any clinical research on human subjects submitted to the Institutional Review Board (IRB) will be analyzed to determine whether a CA will be required.  Additional information can be found on the OCR Coverage Analysis web page. 

In addition to the Coverage Analysis charge designations for your research study, the OCR offers budget creation and negotiation services. The OCR works with investigators and their study team to develop budgets for clinical trials and negotiates terms with industry sponsors. OCR Budgets can be developed after a preliminary coverage analysis has been approved, unless fully funded by the Sponsor. Additional information can be found on the OCR Budget web page. 

For more details about study start-up, please also visit the Clinical Research Resource HUB for information on proposal, funding, regulatory tasks, and particpant enrollment. You can also contact the Department's Clinical Research Coordinator, Rachelle Palkovsky [email protected]; PH: (415) 476-8362 for additional questions.