The Clinical Research Support Services Core is one aspect of the Cancer Center's Investigational Therapeutics Initiative. CRSS helps investigators to conduct cancer-related therapeutic or nontherapeutic clinical trials, with an emphasis on institutional studies. Its objectives are to:

• Foster investigator-initiated clinical trials through assistance with protocol development/writing, CHR submission and maintenance, and provision of data management support.
• Provide infrastructure for compliance with federal guidelines for the conduct of clinical studies and for the appropriate distribution of investigational drugs.
• Facilitate the recording and reporting of adverse events.
• Provide education for clinical research coordinators, Cancer Center members, and physicians in order to ensure compliance with clinical trial regulations.
• Provide a centralized online database to collect protocol information and patient registrations.

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Services

Protocol Support and Management
CRSS maintains all institutional protocols (hard copy) in a centralized location, and the online protocol management system Velos contains CHR approval dates, accrual data, and current protocols and consent forms. Study coordinators are responsible for maintaining hard copies of protocols for industry and cooperative group studies. The Core also assists investigators with protocol editing, as needed.

The Velos system manages regulatory and patient data and includes study calendars and other forms useful to study management. The system reports patient enrollment data to the NCI and other entities.

For username and log-in, submit a Request for Access to Sensitive Data form. To schedule training for protocol maintenance, patient registration, or creation or maintenance of study forms or calendars, contact Diane Davies. To schedule training for PRC-related uses, contact prc@cc.ucsf.edu.

IRB, Data Safety, Regulatory Compliance
CRSS is responsible for training PIs and study coordinators in good clinical practices. Staff are available for telephone or on-site consultation. A Protocol Development Group is available for assistance and guidance with applications to the CHR. Contact: Tanya Kocian.

The Data Safety Monitoring Committee is responsible for yearly audits of all therapeutic institutional studies. Contact: Gerry Pelle-Day. (Data Safety Monitoring Plan available upon request.)

See Submitting a Proposal for information about submission processes and deadlines, and see Appendices for information on the Protocol Review Committee and Site Committee chairs and contacts. All forms related to protocol application, budgeting, patient registration, etc., are available here.

Education
A nurse educator is responsible for a six-part CRC orientation program that covers essential duties of a clinical research coordinator and also incorporates UCSF research implementation policies and procedures. Classes are taught by CRSS staff, research nurses, and other medical center staff. In the final class, faculty members participate in a discussion of their oncology research programs. In addition, ongoing seminars are taught by industry experts, faculty members, and Cancer Center research staff. Seminars are categorized as Research Management, Research Ethics, Velos User Groups, Cancer Biology, Cancer Therapies, and Cancer-Related Adverse Events. Contact: Beverly Fein, RN, MSN, CCRP.