The Data and Safety Monitoring System at the University of Texas Southwestern Medical Center (UTSW) Simmons Cancer Center is designed to ensure patient safety and data quality for cancer-related clinical trials. The Data and Safety Monitoring Committee (DSMC) is an independent committee appointed by the Deputy Director of the Cancer Center and is responsible for carrying out the data and safety monitoring plan for the Cancer Center. The DSMC can recommend trial modificafion, suspension, or closure based on safety or regulatory concerns. Recommendafions for trial suspension or closure are implemented through the Deputy Director of the Cancer Center and the IRB. The essenfial funcfions of the DSMC include: Review and tracking of all SAE's reported for cancer-related trials. Full committee review of selected adverse events. Annual systemafic review of all institufional therapeufic trials. Independent evaluation of treatment responses. Invesfigation of potential regulatory compliance violations. Weekly monitoring of toxicities and systematic review of all first accruals to Phase I trials. Comprehensive documentafion auditing for 10% of all cancer-related clinical trials. Serves as the DSMC for any therapeufic trial lacking a DSMC. The DSMC membership consists of a Chairperson and Co-Chairperson, and representation from biostafistics, nursing, regulatory, pharmacy, and faculty. Faculty members are selected from all the oncology treatment modalifies (Surgery, Radiation Oncology and Medical Oncology). A DSMC Coordinator provides administrative support for all of the DSMC activifies and a Quality Assurance &Educafion Coordinator conducts the internal audits.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
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Subcommittee G - Education (NCI)
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University of Texas Sw Medical Center Dallas
United States
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Huang, Xiumei; Motea, Edward A; Moore, Zachary R et al. (2016) Leveraging an NQO1 Bioactivatable Drug for Tumor-Selective Use of Poly(ADP-ribose) Polymerase Inhibitors. Cancer Cell 30:940-952
Singal, Amit G; Gupta, Samir; Tiro, Jasmin A et al. (2016) Outreach invitations for FIT and colonoscopy improve colorectal cancer screening rates: A randomized controlled trial in a safety-net health system. Cancer 122:456-63
Knudsen, Erik S; O'Reilly, Eileen M; Brody, Jonathan R et al. (2016) Genetic Diversity of Pancreatic Ductal Adenocarcinoma and Opportunities for Precision Medicine. Gastroenterology 150:48-63
Gallardo-Montejano, Violeta I; Saxena, Geetu; Kusminski, Christine M et al. (2016) Nuclear Perilipin 5 integrates lipid droplet lipolysis with PGC-1α/SIRT1-dependent transcriptional regulation of mitochondrial function. Nat Commun 7:12723
Skinner, Celette Sugg; Gupta, Samir; Halm, Ethan A et al. (2016) Development of the Parkland-UT Southwestern Colonoscopy Reporting System (CoRS) for evidence-based colon cancer surveillance recommendations. J Am Med Inform Assoc 23:402-6
McNamara, Ryan P; Reeder, Jonathan E; McMillan, Elizabeth A et al. (2016) KAP1 Recruitment of the 7SK snRNP Complex to Promoters Enables Transcription Elongation by RNA Polymerase II. Mol Cell 61:39-53
Belfatto, Antonella; White, Derek A; Mason, Ralph P et al. (2016) Tumor radio-sensitivity assessment by means of volume data and magnetic resonance indices measured on prostate tumor bearing rats. Med Phys 43:1275-84
Wylie, Annika; Jones, Amanda E; D'Brot, Alejandro et al. (2016) p53 genes function to restrain mobile elements. Genes Dev 30:64-77
Fernando, W Shirangi; Martins, André F; Zhao, Piyu et al. (2016) Breaking the Barrier to Slow Water Exchange Rates for Optimal Magnetic Resonance Detection of paraCEST Agents. Inorg Chem 55:3007-14
Singal, Amit G; Tiro, Jasmin A; Marrero, Jorge A et al. (2016) Mailed Outreach Program Increases Ultrasound Screening of Patients with Cirrhosis for Hepatocellular Carcinoma. Gastroenterology :

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