The Clinical Trials Informatics and Biostatistics Core (CTIBC) serves as a centralized resource to the? investigators of the Hematopoietic Cell Transplantation (HCT) for Hematologic Malignancies Program Project? Grant (PPG), providing biostatistical expertise, clinical research management and informatics resources to all? projects. The CTIBC includes 2 Core Co-Directors, 2 Senior Biostatisticians, 2 Masters Biostatisticians, a? Clinical Trials Administrator, 5 Clinical Research Associates (CRAs), Quality Assurance (QA) and Data? Operation Sections, data entry, and the Phoenix BMT Coordinator. The CTIBC provides study design, sample? size projections, analytic planning, statistical programming, analysis of study results, and collaboration in? writing abstracts and peer-review publications. Statistical analyses are performed using the SAS and S-PLUS? software packages, and specialty software. The CTIBC provides coordination of multi-centered studies,? including documentation of site IRB approval, common Case Report Forms (CRFs), staff training, verification? of subject eligibility, central patient registration, data collection, expectation and quality checking, and? centralized data analyses. A centralized clinical trials database system (BITS) was developed in-house and? has been in continual use for the past 15 years. BITS contains data on all bone marrow transplant recipients to? date, including the data collected by the Long Term Follow-up Core (Core C). The CTIBC has developed? customized data collection instruments specific to the patient populations under study, using a modular forms? design approach and implemented via scannable forms. The CRAs provide protocol management and data? collection for the clinical studies, and the QA team conducts training, review of data, and audits of in-house? protocols. Additional support is provided to the PPG by members of the Division of Information Sciences (DIS)? within which the CTIBC is housed, including expertise from the Department of Biomedical Informatics, at no? additional cost to the grant. This support includes resources and expertise in the creation and maintenance of? information systems and tools, such as integration of electronic medical record data (demographics, lab results,? HLA, vital status) with the BITS database, and automation of CTC grading, in collaboration with PPG? investigators (see Core A). During the last funding period CTIBC members were co-authors of 45 publications? and over 50 abstracts. The CTIBC has been involved in study design for each specific aims of the current? proposal, and will continue to be a critical component to successful conduct of the PPG.
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