The Data Safety Monitoring/Quality Assurance Committee (DSM/QAC) ensures the safety of patients who are subjects in clinical research at the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC). UMGCC's DSM/QAC reviews in an ongoing fashion Severe Adverse Events (SAEs), internal and external, to define whether expedited reporting to the Institutional Review Board (IRB) ofthe University of Maryland School of Medicine (UMSOM) and/or altering informed consent is warranted. UMGCC's DSM/QAC is recognized by IRB as the DSM body of record for UMGCC protocols that do not have a freestanding, independent DSM process. DSM/QAC reviews in that capacity the following types of protocols: investigator-initiated trials of any phase, all Phase I trials irrespective of sponsor, and NCI-sponsored or corporate Phase II trials for which an independent DSM committee is not active. On at least an annual basis, this entails reviewing the currency and accuracy of the consent form, the protocol regulatory binder, response rates, audit results, and whether accrual during the review period is within the allowed enrollment according to the latest IRB review. DSM/QAC will review audits contracted to and performed by UMSOM's IRB of 50 percent of patients accrued to the protocol types under its purview. DSM/QAC may also direct its own audits, as necessary, of trials under DSM/QAC purview. The timing of the DSM/QAC review is prior to the annual IRB review. Finally, in pursuing its institutional mandate to provide real-time governance of the conduct of early-phase clinical trials, DSM/QAC will also assess Phase I studies for dose-limiting toxicities after each cohort, before dose escalation, and semiannually. DSM/QAC meets monthly and requires a quorum of three members. For calendar year 2009, 129 actions occurred at DSM/QAC meetings. Of these, 93 were annual reviews of protocols, 9 were safety reviews, 13 were reviews of responses from principal investigators to previous queries from DSM/QAC, and 12 were reviews of internal safety reviews or IRB conducted audits, with two protocols suspended as a result (counted as distinct actions). Of the 93 annual reviews, 78 were approved for continuance;12 remained open but had corrective actions prescribed;and 3 were referred for consideration of closure by the Clinical Research Committee, all with poor accruals.

Public Health Relevance

The conduct of clinical trials, particularly those sponsored by UMGCC with funding from the Cancer Center Support Grant (CCSG), requires assurance of quality and safety on a continuing basis to participants. DSM/QAC is the means for that to be accomplished according to an organized plan approved by NCI in its latest iteration on June 23, 2009, and formulated in response to the prior UMGCC CCSG review in 2008. DSM/QAC function is therefore central to the quality execution of sponsored clinical research at UMGCC.

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National Cancer Institute (NCI)
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Subcommittee G - Education (NCI)
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Nygård, Lotte; Vogelius, Ivan R; Fischer, Barbara M et al. (2016) Early lesion-specific (18)F-FDG PET response to chemotherapy predicts time to lesion progression in locally advanced non-small cell lung cancer. Radiother Oncol 118:460-4
Fox, Jennifer M; Moynihan, James R; Mott, Bryan T et al. (2016) Artemisinin-derived dimer ART-838 potently inhibited human acute leukemias, persisted in vivo, and synergized with antileukemic drugs. Oncotarget 7:7268-79
Joseph, Ann Mary; Srivastava, Ratika; Zabaleta, Jovanny et al. (2016) Cross-talk between 4-1BB and TLR1-TLR2 Signaling in CD8+ T Cells Regulates TLR2's Costimulatory Effects. Cancer Immunol Res 4:708-16
Zandberg, Dan P; Liu, Sandy; Goloubeva, Olga et al. (2016) Oropharyngeal cancer as a driver of racial outcome disparities in squamous cell carcinoma of the head and neck: 10-year experience at the University of Maryland Greenebaum Cancer Center. Head Neck 38:564-72
Doshi, Kshama A; Trotta, Rossana; Natarajan, Karthika et al. (2016) Pim kinase inhibition sensitizes FLT3-ITD acute myeloid leukemia cells to topoisomerase 2 inhibitors through increased DNA damage and oxidative stress. Oncotarget 7:48280-48295
Ambulos Jr, Nicholas P; Schumaker, Lisa M; Mathias, Trevor J et al. (2016) Next-Generation Sequencing-Based HPV Genotyping Assay Validated in Formalin-Fixed, Paraffin-Embedded Oropharyngeal and Cervical Cancer Specimens. J Biomol Tech 27:46-52
Temburnikar, Kartik W; Ross, Christina R; Wilson, Gerald M et al. (2015) Antiproliferative activities of halogenated pyrrolo[3,2-d]pyrimidines. Bioorg Med Chem 23:4354-63
Kochel, Tyler J; Fulton, Amy M (2015) Multiple drug resistance-associated protein 4 (MRP4), prostaglandin transporter (PGT), and 15-hydroxyprostaglandin dehydrogenase (15-PGDH) as determinants of PGE2 levels in cancer. Prostaglandins Other Lipid Mediat 116-117:99-103
Rasmussen, Jacob H; Vogelius, Ivan R; Aznar, Marianne C et al. (2015) Spatio-temporal stability of pre-treatment 18F-Fludeoxyglucose uptake in head and neck squamous cell carcinomas sufficient for dose painting. Acta Oncol 54:1416-22
Shih, Yu-Huan; Zhang, Yuji; Ding, Yonghe et al. (2015) Cardiac transcriptome and dilated cardiomyopathy genes in zebrafish. Circ Cardiovasc Genet 8:261-9

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