The CPDMU is a Shared Resource used by all AECC clinical cancer researchers that provides centralized management, communication, and oversight of all cancer clinical trials at the AECC. The CPDMU provides a central location for processing of all cancer related protocols, interaction with internal (e.g., IRB) and external (e.g., NCI, industry) agencies, and communication. The scope of work performed by the CPDMU includes processing of initial protocol submissions, amendments, internal and external safety and/or adverse event reports, and annual IRB progress reports, as well as patient registration, radiology review/tumor measurement, Data and Safety Monitoring Committee (DSMC reports, data management, and quality assurance). The CPDMU also supports other components of the clinical trials infrastructure, including the Protocol Review and Monitoring System (PRMS) and Protocol Specific Research Support (PSRS). Upon protocol activation, an announcement is distributed to all AECC investigators, and an updated list of currently active protocols is distributed on a monthly basis. The protocol status (open, suspended, closed to accrual) and most recently approved version of the protocol and IRB-approved consent is also posted on the CPDMU website so that it is accessible to all health care providers and research associates. Quality control functions include centralized education and training services for physicians, research nurses, physician assistants, and study coordinators. During the July 1, 2011 to June 30, 201212 grant year, the CPDMU processed 124 new protocols and 525 protocol amendments for review by the Protocol Review and Monitoring Committee (PRMC) and IRB, 5136 adverse events and 26 protocol monitoring reports for the DSMC, and 670 patient registrations requiring data management and processing.

Public Health Relevance

The Central Protocol and Data Management Unit (CPDMU) provides centralized management communication, and oversight for all cancer related clinical trials at the Albert Einstein Cancer Center (AECC). As an NCI-designated Cancer Center, AECC contributes to the national effort to reduce morbidity and mortality from cancer.

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Center Core Grants (P30)
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Subcommittee B - Comprehensiveness (NCI)
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Albert Einstein College of Medicine
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Peregrina, Karina; Houston, Michele; Daroqui, Cecilia et al. (2015) Vitamin D is a determinant of mouse intestinal Lgr5 stem cell functions. Carcinogenesis 36:25-31
Kim, Ryung S (2015) A new comparison of nested case-control and case-cohort designs and methods. Eur J Epidemiol 30:197-207
Stanley, Pamela (2014) Galectin-1 Pulls the Strings on VEGFR2. Cell 156:625-6
Yamane, Fumihiro; Nishikawa, Yumiko; Matsui, Kazue et al. (2014) CSF-1 receptor-mediated differentiation of a new type of monocytic cell with B cell-stimulating activity: its selective dependence on IL-34. J Leukoc Biol 95:19-31
Arora, Pooja; Baena, Andres; Yu, Karl O A et al. (2014) A single subset of dendritic cells controls the cytokine bias of natural killer T cell responses to diverse glycolipid antigens. Immunity 40:105-16
Bahde, Ralf; Kapoor, Sorabh; Viswanathan, Preeti et al. (2014) Endothelin-1 receptor A blocker darusentan decreases hepatic changes and improves liver repopulation after cell transplantation in rats. Hepatology 59:1107-17
Ho, Gloria Y F; Wang, Tao; Zheng, Siqun L et al. (2014) Circulating soluble cytokine receptors and colorectal cancer risk. Cancer Epidemiol Biomarkers Prev 23:179-88
Singh, M; Quispe-Tintaya, W; Chandra, D et al. (2014) Direct incorporation of the NKT-cell activator ?-galactosylceramide into a recombinant Listeria monocytogenes improves breast cancer vaccine efficacy. Br J Cancer 111:1945-54
Kerns, Sarah L; de Ruysscher, Dirk; Andreassen, Christian N et al. (2014) STROGAR - STrengthening the Reporting Of Genetic Association studies in Radiogenomics. Radiother Oncol 110:182-8
Hiraki, Susan; Rinella, Erica S; Schnabel, Freya et al. (2014) Cancer risk assessment using genetic panel testing: considerations for clinical application. J Genet Couns 23:604-17

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