About Clinical Research Support Office
Clinical Research Support Office
The Clinical Research Support Office (CRSO) is divided into 2 units:
The CRSO provides the Helen Diller Family Comprehensive Cancer Center (HDFCCC) with a central core of personnel with expertise in all types of clinical trials management, including protocol project managers (PPMs), protocol development and trial design, and regulatory affairs. The CRSO supports investigators in the conduct of cancer-related therapeutic or nontherapeutic clinical trials, with an emphasis on institutional (investigator-initiated) studies.
The objectives of the CRSO:
- 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, including initial and ongoing training, education, monitoring, and mentorship
- Increase the participation of volunteer subjects in clinical trials with an emphasis on diversity
Policies and Procedures related to study conduct are located on the ITR Policies page.
Research Personnel Unit
The Research Personnel Unit provides:
- Central oversight (hiring and supervising) of research personnel [clinical research coordinators (CRCs), data managers, Protocol Project Managers (PPMs) and Lead CRCs].
Initial and ongoing formal training, education, monitoring, and mentorship for all Lead CRCs, CRCs, data managers and PPMs.
- Development of training program and establishment of competency standards for all research personnel in the HDFCCC.
- Six-week “on-boarding” program that provides training in all university-required certifications, HDFCCC policies and workflows, working in the medical center, research billing, privacy issues, Good Clinical Practices, electronic medical records, and OnCore use.
- Ongoing training and continuing education training based on changes in research policies and regulations including the Code of Federal Regulations, HIPAA, Informed Consent, Adverse Events, Data Management, CITI human research protection, ethics and security, IT and email security, and blood borne pathogen and infection control for non-nurses.
- Standardized procedures and policies for clinical research conducted at the HDFCCC.
- Assistance to staff and investigators with preparation prior to (and following) external audits.
Research Personnel management meets regularly with the Lead CRCs to discuss performance issues, provide training in HR procedures and coaching for success, and to disseminate UCSF and HDFCCC workflows and policies.
Research Personnel management also oversee the Protocol Project Manager (PPM) position in each program. The PPMs work closely with the Lead CRCs to provide seamless and efficient implementation of clinical trials, with a focus on the regulatory pathway. PPMs are protocol navigators and are responsible for:
- Coordinating of all aspects of study development, start-up, and maintenance
- Serving as the principal liaison between:
The Regulatory Unit is divided into two divisions:
The Regulatory Unit provides comprehensive regulatory support to ensure compliance and obtain approval from regulatory review bodies such as Institutional Review Board (IRB), National Cancer Institute (NCI), Food and Drug Administration (FDA), Department of Defense (DOD), in addition to internal UCSF committees including HDFCCC Protocol Review Committee (PRC), and external sponsors, partners and foundations for oncology clinical trials. Regulatory staff work closely with study teams and investigators, and participate in the continuing education of HDFCCC staff. Prioritization for initiating new studies is determined by the different Disease Site Committees to establish the priority order. For renewals and modifications, priority is based on the renewal expiration date, patient safety information and study enrollment status.
For more information about the Regulatory Unit and its services, contact the Director of Regulatory Affairs and Protocols, Mary Burke.
The Protocol Development Unit is responsible for all protocol and regulatory support required for activation, maintenance and close out of internal UCSF institutional investigator initiated trials conducted at the HDFCCC, which includes:
- 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.
The External Sponsor Trials Unit is responsible for human subjects regulatory compliance for trials sponsored outside of UCSF, which includes:
- 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.
Publications generated from use of this facility should appropriately acknowledge the UCSF Helen Diller Family Comprehensive Cancer Center Clinical Research Support Office. Additional Resources A searchable database of core facilities at all UCSF campus locations, provided by the Clinical and Translational Science Institute at UCSF, is available here.
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 more information on the CCSG, please email Erin Bank, PhD.