University of California San Francisco
Helen Diller Family Comprehensive Cancer Center

Clinical Research at HDFCCC

Clinical Research at UCSF


Clinical research at the HDFCCC is supported by four units:

Clinical Research Support Office (CRSO)

Clinical Research Support Office (CRSO)

Clinical Research Programs

  • Provides central oversight and a core of personnel with expertise in all types of clinical trials management
  • Supports investigators in the conduct of cancer-related therapeutic or nontherapeutic clinical trials

Regulatory Affairs

  • Provides protocol development and editing, consent form development, full regulatory compliance, and IND/IDE filing and maintenance
  • Prepare and submit all Institutional Review Board (IRB) applications and ancillary committee applications as needed (radiation safety, biosafety, etc.)

Contact information:

    CRSO Medical Director
    Charalambos (Babis) Andreadis, MD | Charalambos.Andreadis@ucsf.edu

    CRSO Director
    Andrea Skafel, MSc, CCRP | Andrea.Skafel@ucsf.edu

Protocol Review and Monitoring System (PRMS)

Protocol Review and Monitoring System (PRMS)

Site Committees

  • Disease or modality specific scientific and feasibility review
  • Prioritization of each new concept and protocol as it relates to the patient population and research focus of each site committee

Site Committee Chairs and Administrators

Protocol Review Committee (PRC)

  • HDFCCC-wide scientific and feasibility review
  • Monitors for adequate accrual and ongoing scientific relevance, and closes studies that do not accrue or lose scientific relevance.

2020 PRC Meeting Schedule

PRC roster

Contact information:

PRC Chair
Jennifer Clarke, MD, MPH | Jennifer.Clarke@ucsf.edu

PRMS Manager
Tanya Kocian | Tanya.Kocian@ucsf.edu

Data and Safety Monitoring Committee (DSMC)

Data and Safety Monitoring Committee (DSMC)

Monitoring Office

  • Monitoring and Auditing of interventional IITs and NCI cooperative group trials
  • Preparation of study teams for external audits and inspections

Education and Training Office (MyAccess login required)

  • Onboarding and continual education of clinical research staff
  • The following training/resources are available:
    • CRC Onboarding Series
    • Regulatory Training Series
    • Investigator Training
    • Continual Education
    • SoCRA Exam Preparation

DSMP with Templates for Protocol (v Dec 2017)

DSMP Monitoring Templates (v 12 Jun 2020)

DSMC Roster (v 2 Jul 2020)

Policy for Data and Safety Monitoring of Phase I Single Site and MCT Trials (v 12 Dec 2019)

Policy for Data and Safety Monitoring of Phase II or III Single Site and MCT Trials (v 23 Jan 2020)

 

Contact Information:

DSMC Chair
Katie Kelley, MD | Katie.Kelley@ucsf.edu

DSMC Director
John F. McAdams, MS, CCRP | John.McAdams@ucsf.edu

Clinical Research Network Office (CRNO)

Clinical Research Network Office (CRNO)

Regional Affiliate Partnerships

  • Develop, streamline and improve oncology clinical research opportunities at partner sites around the bay area

National Clinical Trials Network (NCTN)

  • Manage the  UCSF NCTN program and all associated affiliate sites

Contact Information:

CRNO Medical Director
Mary Feng, MD |  Mary.Feng@ucsf.edu

CRNO Director
Arla Yost, MSc, CCRP  | Arla.Yost@ucsf.edu

These units are guided by the Cancer Center Clinical Research Oversight Committee (CCCROC).

 



Together the units provide a centralized mechanism to support cancer clinical research and assist HDFCCC members with conducting clinical studies in compliance with all federal, state and local regulatory requirements.


Additional Resources

This unit is supported by a National Cancer Institute Cancer Center Support Grant (P30CA082103). Any publications related to work done by this core should reference grant number P30CA082103 and must include a PMCID as required by the NIH. View instructions on how to acknowledge funding sources and how to obtain a PMCID.

For inquiries about Cancer Center Shared Resources, please email Benjamin Braun, MD, PhD.