Clinical Trials Core
Medical Director: Jeff Michalski, MD
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 and data management. For more information, please contact the appropriate individual.
- Protocol Development staff provide expertise and research assistance in the following areas: study design; protocol and consent form development and editing; preparation of all regulatory paperwork, including PRMC forms, institutional review board forms, IND/IDE applications to the FDA, development of forms for data collection, registration with Clinical Trials.gov and the NCI Clinical Trials Reporting Program (CTRP); and creation of specifically defined databases (including ClinPortal EDC). Records, documentation and full copies of clinical trials managed by the CTC will be kept in electronic files. Information is also available through the Siteman database, and additional copies will be distributed to relevant clinical personnel. This service is available to all cancer center research and research associate members at no charge. For clinicians and affiliates, there is no charge if the protocol results in a therapeutic trial. For nonmembers, affiliates and clinicians who request assistance with nontherapeutic protocols, there is an hourly fee for any support provided after an initial consult with the protocol development team. Please contact Stephanie Myles, Senior Protocol Development Coordinator at 314-747-4223 or email@example.com.
- 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 IRB. Records, documentation and full copies of clinical trials managed by the CTC will be kept in electronic files. Information is also available through the Siteman database, and additional copies will be distributed to relevant clinical personnel. This service is available to all cancer center members for a fee. Please contact Chloe Fournier at 314-747-4235.
- Study Coordination staff members 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. In addition, the office assists investigators with budget and contract development and other study-related activities. These services are available to all cancer center members for a fee. Please contact Lindsey Brunt at 314-362-6532 or firstname.lastname@example.org.
Internal Education and Training
The Siteman Cancer Center Clinical Trials Core Education Program conducts a variety of educational sessions for new hires and established staff. Initially all new hires (in all job positions) receive the basic New Hire Orientation which consists of 3 sessions that are 3 hours each. Topics range from performance expectations, to protocol interpretation, informed consent process, research ethics and data integrity. Within a month, these sessions are followed by educational sessions targeting specific job roles and responsibilities (clinical, data, etc.). A comprehensive exam is completed by new staff pre and post orientation and again at 5 months to measure effectiveness of the education program. All staff are required to attend annual refreshers on informed consent and eligibility and whenever an event triggers an educational opportunity. These sessions are in addition to mandatory university requirements such as CITI and HIPAA training.
Education for External Sites
The Siteman Cancer Center Clinical Trials Core Education Program also offers an 8 hour educational opportunity for external sites interested in general education for oncology clinical research. Topics include an overview of clinical research, research ethics, protocol interpretation, eligibility, informed consent process, data management, review of common lab values and interpretation, chemotherapy orders, Common Terminology Criteria for Adverse Events (CTCAE) and reportable events. This general education is followed by a “real world” shadowing session with role playing, form completion and a tour of the clinical research facilities.
For more information please contact Amanda DeMoss at email@example.com 314-747-4536.
The core also provides clinical trials tools, Siteman web postings and electronic access to protocol documents via the Siteman database here.
LOCATION: Barnes-Jewish Hospital Center for Outpatient Health(BJHCOH), eighth floor
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/classes-consulting/specialized-expertise/nih-public-access-policy for more information.
DOCUMENT USAGE: If research supported by the Clinical Trials Core results in publication, please acknowledge this support by including the following in your publication(s): We would like to thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis, Missouri, for the use of the Clinical Trials Core which provided __________ service. The Siteman Cancer Center is supported in part by NCI Cancer Center Support Grant #P30 CA91842.
Siteman Database Access Form (for internal use only)