The AECOM/AECC Data Safety monitoring plan establishes implementation plans for the policies set forth by the National Cancer Institute in the document entitled "Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials" ( These policies pertain to the monitoring of all clinical trials supported by NCI, and thus encompass all NCI funded clinical trials, intramural, multicenter and cooperative group. The policies and procedures for Data and Safety Monitoring of the clinical research programs at the AECC are established and monitored by the Protocol Review and Monitoring Committee and the Cancer Center Clinical Research Executive Committee. The Data Safety Monitoring Committee is a major component of the Cancer Center and reports directly to the head of the Protocol Review and Monitoring Committee, the CPDMU, the Cancer Center Director and the AECOM/Montefiore IRBs. The document includes the major functions and responsibilities of data and safety monitoring of our active clinical trials program(s) and includes a detailed description of the following: Individual responsible for monitoring The frequency of the review A description of what is being monitored The procedures for different classes of clinical trials The evaluation and investigator feedback/communication process The procedures for managing and averting conflicts of interest Adverse event procedures Suspensions of clinical trials Protocol compliance auditing procedures The Data Safety Monitoring Committee (DSMC) has the responsibility for ensuring data and safety monitoring along with each of the protocol Principal Investigators who are ultimately responsible for the ongoing monitoring and safety of clinical protocols. The DSMC is comprised of investigators from throughout the College and Cancer Center, and have a variety of different expertise. Dr. Richard Gorlick chairs the DSMC. The remainder of the membership is listed in the table below. The DSMC is provided with administrative support, database management, etc., by the CPDMU. The DSMC meeting occurs immediately prior to the PRMC meeting to ensure immediate transmission of information. Representatives of the CCI and PRMC serve in a non-voting capacity on the DSMC to assure communication.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Albert Einstein College of Medicine
United States
Zip Code
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
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
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
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
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
Ghartey, Jeny P; Smith, Benjamin C; Chen, Zigui et al. (2014) Lactobacillus crispatus dominant vaginal microbiome is associated with inhibitory activity of female genital tract secretions against Escherichia coli. PLoS One 9:e96659
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

Showing the most recent 10 out of 938 publications