Data and Safety Monitoring/Quality Assurance Committee The University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC) Data and Safety Monitoring and Quality Assurance Committee (DSM/QAC) serves the monitoring function of the Protocol Review and Monitoring System. It monitors patient safety and timely accrual of patients entering three categories of clinical trials at UMGCC: investigator-initiated trials of any Phase;all Phase I trials irrespective of sponsor;and NCI-sponsored or corporate Phase II trials where an independent DSM committee is not active. Cooperative group trials and industry-sponsored Phase III trials do not routinely fall under the purview of DSM/QAC, because these trials have established DSM programs. UMGCC's DSM/QAC is available for use by trials for which a DSM program is absent. According to a timeline that predates submission of a clinical trial's Annual Report to UM's Institutional Review Board (IRB), the DSM/QAC reviews accrual, determines if the rate of accrual allows for completion of the trial within 3-5 years from inception, and examines external and internal severe adverse events and new information from the sponsor to determine if a change in informed consent is warranted. DSM/QAC also performs other activities, including (a) reviewing, through a safety monitor, dose escalations contemplated during Phase I trials at UMGCC, irrespective of sponsor;(b) reviewing, every 6 months, clinical trials that the Clinical Research Committee deems to be of """"""""highest risk"""""""";(c) reviewing monthly reports of external adverse events (AEs) that are received from sponsors to define whether expedited reporting to UM's IRB is warranted and/or altering informed consent is warranted;and (d) collaborating as requested by UM's IRB for prospective monitoring of specific trials or considering the outcome of audits by the IRB. In Fiscal Year 2007, 108 protocols were reviewed;of these, 21 were safety reviews. Of 76 protocols reviewed for continuance, the committee approved 47 (61 percent) as is, approved 10 (13 percent) pending corrective action, closed 8 (11 percent), suspended and/or required 5 (7 percent) to undergo additional review, and deferred 6 (8 percent) until receipt of more information.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA134274-03
Application #
8118103
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2010-08-01
Budget End
2011-07-31
Support Year
3
Fiscal Year
2010
Total Cost
$144,716
Indirect Cost
Name
University of Maryland Baltimore
Department
Type
DUNS #
188435911
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Wang, Lei; Felts, Sara J; Van Keulen, Virginia P et al. (2018) Integrative Genome-Wide Analysis of Long Noncoding RNAs in Diverse Immune Cell Types of Melanoma Patients. Cancer Res 78:4411-4423
McCusker, Michael G; El Chaer, Firas; Duffy, Alison et al. (2018) Combination of Blinatumomab and Vincristine Sulfate Liposome Injection for Treatment of Relapsed Philadelphia Chromosome Positive B-cell Acute Lymphoblastic Leukemia. Am J Leuk Res 2:
Wang, Junxiang; Zhao, Liang; Ye, Yanfang et al. (2018) Adverse event detection by integrating twitter data and VAERS. J Biomed Semantics 9:19
Furusawa, Aki; Reiser, John; Sadashivaiah, Kavitha et al. (2018) Eomesodermin Increases Survival and IL-2 Responsiveness of Tumor-specific CD8+ T Cells in an Adoptive Transfer Model of Cancer Immunotherapy. J Immunother 41:53-63
Nathenson, Michael J; Conley, Anthony P; Sausville, Edward (2018) Immunotherapy: A New (and Old) Approach to Treatment of Soft Tissue and Bone Sarcomas. Oncologist 23:71-83
Wang, Lei; Felts, Sara J; Van Keulen, Virginia P et al. (2018) Exploring the effect of library preparation on RNA sequencing experiments. Genomics :
Nathenson, Michael J; Barysauskas, Constance M; Nathenson, Robert A et al. (2018) Surgical resection for recurrent retroperitoneal leiomyosarcoma and liposarcoma. World J Surg Oncol 16:203
Sallmyr, Annahita; Tomkinson, Alan E (2018) Repair of DNA double-strand breaks by mammalian alternative end-joining pathways. J Biol Chem 293:10536-10546
Kerr, Candace; Adhikary, Gautam; Grun, Daniel et al. (2018) Combination cisplatin and sulforaphane treatment reduces proliferation, invasion, and tumor formation in epidermal squamous cell carcinoma. Mol Carcinog 57:3-11
Connolly, Sean; Quasi-Woode, Devona; Waldron, Laura et al. (2018) Calcineurin Regulatory Subunit Calcium-Binding Domains Differentially Contribute to Calcineurin Signaling in Saccharomyces cerevisiae. Genetics 209:801-813

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