Overview: The focus of scientific monitoring Is the application of quality assurance procedures and standards to monitor the overall scientific progress of institutional clinical trials and to ensure adherence to clinical trial and GCP requirements. This Includes review of the overall progress of each study-to ensure the safety of participants;validity of data, that the projected accrual goals are met on a timely basis, that excess accrual is avoided, that eligibility and evaluabillty rates do not fall below minimum acceptable standards, that stopping rules are appropriately adhered to, that risks are not excessive, and that adverse events are appropriately monitored and reported to the appropriate agencies. Inherent in this process is the goal of enhandng the quality of the research by providing the investigator with constructive criticism. The level of monitoring for each clinical trial is based on the degree of risk imposed by the research, judged Initially by the Cancer Protocol Committee, which classifies each study and assigns a monitoring level. Audits are then triggered by accrual milestones based on this Initial assessment. Scientific progress reviews occur, minimally, annually, and more frequently as determined by audit findings.

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Subcommittee G - Education (NCI)
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Duke University
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Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K et al. (2015) Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis. Cancer 121:77-83
Pruszynski, Marek; Koumarianou, Eftychia; Vaidyanathan, Ganesan et al. (2014) Improved tumor targeting of anti-HER2 nanobody through N-succinimidyl 4-guanidinomethyl-3-iodobenzoate radiolabeling. J Nucl Med 55:650-6
Batinic-Haberle, Ines; Tovmasyan, Artak; Roberts, Emily R H et al. (2014) SOD therapeutics: latest insights into their structure-activity relationships and impact on the cellular redox-based signaling pathways. Antioxid Redox Signal 20:2372-415
Sachdeva, Mohit; Mito, Jeffrey K; Lee, Chang-Lung et al. (2014) MicroRNA-182 drives metastasis of primary sarcomas by targeting multiple genes. J Clin Invest 124:4305-19
Tovmasyan, Artak; Carballal, Sebastian; Ghazaryan, Robert et al. (2014) Rational design of superoxide dismutase (SOD) mimics: the evaluation of the therapeutic potential of new cationic Mn porphyrins with linear and cyclic substituents. Inorg Chem 53:11467-83
Azrad, Maria; Demark-Wahnefried, Wendy (2014) The association between adiposity and breast cancer recurrence and survival: A review of the recent literature. Curr Nutr Rep 3:9-15
Blair, Cindy K; Madan-Swain, Avi; Locher, Julie L et al. (2013) Harvest for health gardening intervention feasibility study in cancer survivors. Acta Oncol 52:1110-8
Mito, Jeffrey K; Min, Hooney D; Ma, Yan et al. (2013) Oncogene-dependent control of miRNA biogenesis and metastatic progression in a model of undifferentiated pleomorphic sarcoma. J Pathol 229:132-40
Pruszynski, Marek; Koumarianou, Eftychia; Vaidyanathan, Ganesan et al. (2013) Targeting breast carcinoma with radioiodinated anti-HER2 Nanobody. Nucl Med Biol 40:52-9
Hover, Bradley M; Loksztejn, Anna; Ribeiro, Anthony A et al. (2013) Identification of a cyclic nucleotide as a cryptic intermediate in molybdenum cofactor biosynthesis. J Am Chem Soc 135:7019-32

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