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 Committee
STEP 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]
Complete HDFCCC training before proceeding to Step 2.
- Determine review level:
- You may either refer to the PRMC Review Policy for review levels, or email your IRB Study Application (or protocol document if available) to [email protected] for review level assessment.
- 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
- Submit a protocol review request to the DSMC
- Following Site Committee approval:
- Obtain an OnCore account
- Submit to the Protocol Review and Monitoring Committee (PRMC)
- For more detail, see PRMS review requirements
Submit for MCA, Budget, and Contracts before proceeding to Step 5.
- UCSF IRB
- Review PRMS review requirements
Email HDFCCC Research Compliance at [email protected]
► Study open to accrual
Follow these steps AFTER study is open to complete the trial process:
Other Clinical Research Resources