Medical Director: Jeff Michalski, MD
Administrative Director: Roberta Yoffie, Director of the Clinical Trials Office, Siteman Cancer Center

The Siteman Cancer Center Clinical Trials Core (CTC) promotes excellence in cancer research for human subjects and provides support to all investigators in the cancer center for clinical research activities. Comprehensive services are available through the CTC for all aspects of protocol development, regulatory submissions, study coordination, data management and education and training of the clinical trials staff.

• Protocol development staff provide expertise and research assistance in the following areas: study design; protocol and consent form development and editing; biostatistical support; development of frameworks, methods and forms for data collection; and creation of specifically defined databases. For protocols without a funding source this service is available to all Cancer Center members at no charge. For protocols with a funding source or a pending funding source there will be an administrative protocol development fee based on complexity of the protocol submission.
• Regulatory services include management of all regulatory affairs – from protocol submission and processing of protocol-related actions and documents to trial closeout – as well as working with the Protocol Review and Monitoring Committee (PRMC), Quality Assurance and Safety Monitoring Committee (QASMC) and Human Studies Committee (HSC, WU IRB).
• Study coordination staff provide services in all aspects of trial conduct and data management, including but not limited to: trial logistics assessment; eligibility verification; study coordination; data collection; record retention; data safety and monitoring reporting; audit and monitoring preparation; adverse event assessment and reporting; and data summary completion for analysis.
• Education and Training of the Clinical Trials staff is provided by an aggressive orientation and training program.  Additionally, the program provides continuing education opportunities to the staff.  This service is currently available to the CTC staff on an ongoing basis and other oncology staff on an as needed basis.

In addition, the CTC assists investigators with identification of potential funding sources, budget and contract development and other study-related activities. The core also provides clinical trials tools, such as a comprehensive Siteman Cancer Center protocol index, Web postings and electronic access to protocol documents.

LOCATION: For administration and study coordination, Center for Advanced Medicine, seventh floor. For regulatory affairs, Barnes-Jewish Hospital North, Kingshighway Building, Suite 3600.

TO ACCESS: Call Roberta Yoffie at 314-747-1194 or e-mail yoffier@ccadmin.wustl.edu.

As of April 7, 2008, the NIH requires investigators with a publication using Siteman (or other NIH-funded) shared resources to submit (or have submitted for them) their final, peer reviewed manuscripts to PubMed Central(PMC) upon acceptance of publication, to be made publicly available within 12 months of publication. Many journals automatically submit these for authors, but Washington University also has assistance available through the Becker Medical Library. Please see http://publicaccess.nih.gov/FAQ.htm#b7 or http://becker.wustl.edu/services/scholarly/nihpolicy.html for more information.

PUBLICATION ACKNOWLEDGEMENT: If research supported by the Clinical Trials Core results in publication, please acknowledge this support by including the following in your publication(s):

We thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Mo., for the use of the Clinical Trials Core, which provided __________ service. The Siteman Cancer Center is supported in part by an NCI Cancer Center Support Grant #P30 CA91842.