Follow these steps to prepare a cancer clinical trial to open at UCSF:
If your study has sites outside the USA, please reach out to the Global Cancer Program before proceeding with the steps below.
STEP 1: Draft protocol using HDFCCC template [Complete HDFCCC training] STEP 2: Submit to appropriate HDFCCC Site CommitteeSTEP 3: HDFCCC Data and Safety Monitoring Committee (DSMC) protocol review and approval STEP 4: Submit to HDFCCC Protocol Review and Monitoring Committee (PRMC)[Submit for MCA, Budget, and Contracts] STEP 5: Submit to the UCSF IRB STEP 6: Ensure all Regulatory & Contractual requirements are met [Contact HDFCCC Research Compliance to register with ct.gov and CTRP]
- Determine review level:
- Contact the appropriate HDFCCC Site Committees to request review
- If full committee or expedited review is required, the Site Committee will expect to be provided with a complete protocol which includes all Cancer Center required components (if writing a UCSF investigator-initiated protocol, see Step 1 above for templates; if submitting a protocol from another institution or sponsor, use the protocol provided)
- For more detail, see PRMS review requirements
► Study open to accrual