About Clinical Research Support Office
Clinical Research Support Office
The Clinical Research Support Office (CRSO) is divided into 2 units:
- Improve time to protocol activation for industry, cooperative group and investigator-initiated clinical trials
- Increase the quantity of new investigator-initiated clinical trials
- Improve the quality of existing and new investigator-initiated clinical trials
- Facilitate the translational research efforts of the HDFCCC by providing assistance in streamlined protocol development, protocol activation, implementation and data capture
- Provide central oversight of research personnel
- Increase the participation of volunteer subjects in clinical trials with an emphasis on diversity
Research Personnel Unit
- Central oversight (hiring and supervising) of research personnel [clinical research coordinators (CRCs), data managers, Protocol Project Managers (PPMs) and Clinical Research Managers (CRMs)].
- Standardized procedures and policies for clinical research conducted at the HDFCCC.
- Assistance to staff and investigators with preparation prior to (and following) external audits.
- Coordinating of all aspects of study development, start-up, and maintenance
- Serving as the principal liaison between:
Protocol Development Unit
- Regulatory compliance with federal agencies, internal UCSF review process and committees, and other collaborating sponsors, partners or foundations;
- Ensuring quality research design by HDFCCC standards;
- Working with investigators to develop protocols and informed consent form(s) from initial protocol draft, through all regulatory approvals, and to final version;
- Amending existing investigator-initiated protocols satisfying all internal requirements at UCSF and HDFCCC, in addition to federal requirements;
- Maintenance of HDFCCC protocol templates for investigator-initiated studies; and,
- Management of active INDs.
- External Sponsor Trials Unit
- Development of informed consent forms that meet IRB standards as well as the sponsor requirements;
- Submission of new and amended protocols to the IRB; and,
- Interfacing with IRB staff; both internal and external IRBs.
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.