Morris Cotton Cancer Center (NCCC) at Dartmouth-Hitchcock Medical Center (DHMC) places the highest priority on ensuring the safety of patients participating in clinical trials. The Director of Morris Cotton Cancer Center at Dartmouth holds the overall responsibility for overseeing data and safety monitoring. Groups with responsibilities for data and safety monitoring include the Clinical Cancer Research Committee (CCRC), the NCCC Safety and Data Monitoring Committee (SDMC), the internal auditing system of the Office of Clinical Research (OCR), outside/independent data safety and monitoring boards, the principal investigators of NIH grants and contracts supporting clinical trials, and, most importantly, the Dartmouth principal investigator of each clinical trial. Every clinical trial conducted at the NCCC must include a plan for safety and data monitoring as part of the protocol. The monitoring plans and reporting requirements are dependent upon the study sponsor, nature of the investigational agent (i.e., drug, biologic product or device), and phase of trial. Specific plans may vary based on the degree of risk involved in participation and the size and complexity of the clinical trial. The OCR submits reports to the SDMC on all active Dartmouth clinical trials that are not monitored by another Data and Safety Monitoring Board (DSMB). The NCCC SDMC, which oversees the monitoring of patient safety, scientific integrity, protocol enrollment, and progress toward protocol endpoints while trials are in progress and also at the completion of trials, operates in accordance with National Institutes of Health (NIH) guidelines for safety and data monitoring committees. The SDMC reviews the progress of each protocol and is empowered to take any actions deemed necessary in order to protect safety, assure integrity of scientific data, and facilitate the timely completion of studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA023108-35
Application #
8463402
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
2014-11-30
Budget Start
2012-12-01
Budget End
2013-11-30
Support Year
35
Fiscal Year
2013
Total Cost
$25,659
Indirect Cost
$9,419
Name
Dartmouth College
Department
Type
DUNS #
041027822
City
Hanover
State
NH
Country
United States
Zip Code
03755
Shee, Kevin; Jiang, Amanda; Varn, Frederick S et al. (2018) Cytokine sensitivity screening highlights BMP4 pathway signaling as a therapeutic opportunity in ER+ breast cancer. FASEB J :fj201801241R
Rodriguez-Garcia, Marta; Fortier, Jared M; Barr, Fiona D et al. (2018) Aging impacts CD103+ CD8+ T cell presence and induction by dendritic cells in the genital tract. Aging Cell 17:e12733
Shajani-Yi, Zahra; de Abreu, Francine B; Peterson, Jason D et al. (2018) Frequency of Somatic TP53 Mutations in Combination with Known Pathogenic Mutations in Colon Adenocarcinoma, Non-Small Cell Lung Carcinoma, and Gliomas as Identified by Next-Generation Sequencing. Neoplasia 20:256-262
Szczepiorkowski, Zbigniew M; Burnett, Christine A; Dumont, Larry J et al. (2018) Apheresis buffy coat collection without photoactivation has no effect on apoptosis, cell proliferation, and total viability of mononuclear cells collected using photopheresis systems. Transfusion 58:943-950
Bossé, Yohan; Amos, Christopher I (2018) A Decade of GWAS Results in Lung Cancer. Cancer Epidemiol Biomarkers Prev 27:363-379
Pande, Mala; Joon, Aron; Brewster, Abenaa M et al. (2018) Genetic susceptibility markers for a breast-colorectal cancer phenotype: Exploratory results from genome-wide association studies. PLoS One 13:e0196245
Smith, T Jarrod; Sondermann, Holger; O'Toole, George A (2018) Co-opting the Lap System of Pseudomonas fluorescens To Reversibly Customize Bacterial Cell Surfaces. ACS Synth Biol 7:2612-2617
Gorlova, Olga Y; Li, Yafang; Gorlov, Ivan et al. (2018) Gene-level association analysis of systemic sclerosis: A comparison of African-Americans and White populations. PLoS One 13:e0189498
Schmit, Stephanie L; Edlund, Christopher K; Schumacher, Fredrick R et al. (2018) Novel Common Genetic Susceptibility Loci for Colorectal Cancer. J Natl Cancer Inst :
Cai, Yunliang; Wu, Shaoju; Zhao, Wei et al. (2018) Concussion classification via deep learning using whole-brain white matter fiber strains. PLoS One 13:e0197992

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