Cancer Institute A national cancer institute
designated cancer center

Clinical Protocol and Data Management Facility

http://cancer.stanford.edu/trials/admin/

Facility Director: Miriam B. Bischoff, MS, MBA
Faculty Director: Heather Wakelee, MD

Contact

Miriam Bischoff, MS, MBA
Director, Clinical Protocol and Data Management Facility
Clinical Cancer Center Building
Stanford, CA 94305
(650) 498-4536
Fax: (650) 724-4042
E-mail: miriamb@stanford.edu

Overview

The Clinical Protocol and Data Management Facility provides critical support services to all Stanford Cancer Center investigators conducting clinical trials, including administrative support for protocol development, budget preparation and other oversight requirements. The facility provides programs to contribute to quality assurance of performance and the ongoing education of clinical research personnel, coordinate outreach efforts in the Northern California community to increase clinical trials awareness and accrual and promotes interdisciplinary collaborations and translational medical research. The facility additionally oversees the management of the Oncore database.

Services

Centralized administrative support

The faculty and facility directors and research nurse and finance managers provide consultation services to new and junior investigators for clinical trial design, development, budgeting, staffing and regulatory and institutional requirements. The staff of the facility provides documentation preparation services, and the regulatory specialist is responsible for tacking all safety reports. The senior staff assists with hiring and training research nurses, study coodinators and clinical research associates. The facility staff also coordinates study initiation visits by sponsors, prepares for audits by external organizations and assists investigators with management and tracking of National Cancer Institute-sponsored studies.

Centralize and standardize data collection and reporting of
clinical cancer research

The facility oversees data entry into the Cancer Center database of clinical trials information.  With the Oncore application, the staff works in concert with all principal investigators and clinical research staff to ensure that the database is up-to-date. The facility provides training, establishes user access permission and enters new protocol information into Oncore. The quality assurance program of the facility monitors and ensures data accuracy, as well as protocol and regulatory compliance for investigator-initiated trials. The facility also works closely with the Biostatistics Shared Resource and the developing Informatics Shared Resource on software tools and Oncore enhancements for data analysis and sharing.

Educational programs for research staff

The facility presents monthly educational meetings for all research nurses, study coordinators and data managers. The facility also publishes electronically a monthly newsletter to all cancer research faculty and staff regarding updates on administrative and regulatory procedures, meeting announcements and facility services. The monthly clinical trials forum enables researchers to present new and ongoing research studies and results.

Coordinate outreach efforts to increase clinical trials
awareness and accrual

The outreach coordinator initiates partnerships with community organizations to provide cancer information and education to populations most affected by cancer health disparities. The facility’s web site, brochures, dedicated phone line and symposia provide detailed information about cancer clinical trials targeted at patients and families.

Promote interdisciplinary collaborations and translational medical research

The facility co-manages a research laboratory in the Clinical Cancer Center building to assist research staff with special translational research activities required for complex trials. The facility collaborates with Biostatistics Facility, the developing Informatics Facility, the Cancer Epidemiology and Cancer Prevention and Control research programs.

Operation

The facility is located on the second floor of the Clinical Cancer Center building and is open Monday through Friday, from 8 am to 5 pm. Additional office space for operations is located on California Avenue in Palo Alto.

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