Conducting Research on Subjects Diagnosed with, or at Risk for, Cancer

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]

Complete HDFCCC training before proceeding to Step 2.

STEP 2: Submit to appropriate HDFCCC Site Committee

  • 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

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]

Submit for MCA, Budget, and Contracts before proceeding to Step 5.

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]

Email HDFCCC Research Compliance at [email protected]


►   Study open to accrual

Follow these steps AFTER study is open to complete the trial process:

STEP 7: HDFCCC DSMC monitoring of trial

STEP 8: Keep the OnCore record up to date

Other Clinical Research Resources