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Data and Safety Monitoring (ITHS)

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Data and Safety Monitoring, Institute of Translational Health Sciences, 850 Republican St, Seattle, WA 98109
850 Republican Street Seattle Washington 98109 US
(206) 221-1234(206) 221-1234

National Institutes of Health (NIH) policy requires that investigators include a general description of the data and safety monitoring plan for clinical investigations (biomedical and behavioral intervention studies) as part of the research application. ITHS requirements for data and safety monitoring are aligned with requirements from NIH and the National Center for Advancing Translational Sciences (NCATS), which supports the ITHS. Assistance with development of DSMPs is best done early in the process of protocol development and at least prior to submission of the Institutional Review Board (IRB) application. The ITHS Regulatory Support and Compliance (RSC) group offers assistance to investigators in developing an appropriate safety monitoring plan for clinical trials involving human subjects. This service is helpful to investigators in determining whether independent medical monitoring (IMM) and/or a data safety monitoring committee (DMC) is necessary for their study. Investigators and study teams may consult RSC to review their protocol and make recommendations as to the appropriate level of monitoring for their study design.

Available to
Anyone
Resource Type
Core Laboratory
Institution
University of Washington
Institution
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Northwest Metabolomics Research Center, South Lake Union, 850 Republican Street, Seattle, WA 98109 0 mi
(206) 685-4753(206) 685-4753
Welcome to the Northwest Metabolomics Research Center (NW-MRC). The NW-MRC is located at the Univ...
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Quellos High Throughput Screening Core, Institute for Stem Cell and Regenerative Medicine, 850 Republican St., Seattle, WA 98109 0 mi
(206) 616-3115(206) 616-3115
The Quellos High Throughput Screening (HTS) Core specializes in Functional Genomics as well as Dr...
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Tumor Vaccine Group, University of Washington, 850 Republican St, Seattle, WA 98109 0 mi
(206) 534-8557(206) 534-8557
We now know that human tumors are immunogenic and have identified a variety of proteins that act ...
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UW Proteomics Resource, University of Washington at South Lake Union, 850 Republican St, Seattle, WA 98109 0 mi
(206) 616-0659(206) 616-0659
The University of Washington’s Proteomics Resource (UWPR) is a proteomics facility whose mi...
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Histology and Imaging Core, UW Medicine at SLU, Room N310, 850 Republican St., Seattle, WA 98109 0 mi
(206) 685-6517(206) 685-6517
We have extensive experience collaborating with investigators across a broad range of research an...
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Research Coordination Support Services, Institute of Translational Health Sciences, 850 Republican St., Seattle, WA 98109 0 mi
(206) 221-1234(206) 221-1234
The ITHS Research Coordination Center (RCC) provides investigators with trained research support ...
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Institute for Stem Cell and Regenerative Medicine, UW Medicine Research, 850 Republican St, Seattle, WA 98109 0 mi
(206) 685-1954(206) 685-1954
The University of Washington Institute for Stem Cell and Regenerative Medicine (ISCRM) is committ...
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815 Mercer Street, Seattle, WA 98109, United States 0.02 mi
(206) 543-3061(206) 543-3061
The Bio-Molecular Imaging Center’s (BMIC) mission is to develop novel imaging techniques for anat...
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UW Medicine Proteomics Lab, South Lake Union, 815 Mercer St, Seattle, WA 98109 0.02 mi
(206) 616-0659(206) 616-0659
Our current focus is to provide mass spectrometry resources and computational support for the gre...
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VTMC, UW SLU, 815 Mercer St, Seattle, WA 98109 0.02 mi
(206) 543-1681(206) 543-1681
The overall goal of the VTMC is to provide DRC affiliate investigators with state-of-the-art vect...
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UW SLU, 815 Mercer St, Seattle, WA 0.02 mi
The overall goals of the QFPC are to provide the powerful tools of modern mass spectrometry and c...
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South Lake Union Confocal Facility, 815 Mercer St, Seattle, WA 98109 0.02 mi
ronse@uw.eduronse@uw.edu
A Zeiss Confocal Microscope; model LSM510Meta is available to South Lake Union labs. The instrume...
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Veterinary Diagnostic Laboratory, 815 Mercer St. Room 310N, Seattle, WA 98195 0.02 mi
(206) 685-3040(206) 685-3040
The University of Washington Veterinary Diagnostic Laboratory is staffed with veterinary patholog...
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SLU Lab Services, Brotman Building, 815 Republican Street, Seattle, WA 98109 0.05 mi
(206) 685-2720(206) 685-2720
The SLU Lab Services is located in Room B56 of the Brotman Building. The center provides a variet...
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Diabetes and Obesity Center of Excellence, UW Medicine Research, Republican St., Seattle, WA 98109 0.13 mi
(206) 221-0551(206) 221-0551
The Diabetes and Obesity Center of Excellence (DOCE), located at the South Lake Union research ca...
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Institute for Systems Biology, 401 Terry Ave N, Seattle, WA 98109 0.16 mi
(206) 732-1200(206) 732-1200
The Institute for Systems Biology is a premier, nonprofit research organization based in Seattle,...
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Institute for Systems Biology, 401 Terry Avenue North, Seattle, WA 98109 0.17 mi
(206) 732-1200(206) 732-1200
The Image and Cytometry Core Facility at ISB offers microscopy and cytometry tools for cell purif...
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Center for Infectious Disease Research, 307 Westlake Ave N, Suite 500, Seattle, WA 98109 0.2 mi
(206) 256-7200(206) 256-7200
We believe that targeted research is the first step toward conquering any disease. Our world-clas...
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3T Whole-Body MRI, South Lake Union Bio-Medical Imaging Center, Seattle, WA 98109 0.42 mi
(206) 616-1697(206) 616-1697
3T Whole-Body MRI available at UW South Lake Union Bio-Medical Imaging Center.
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Institute of Translational Health Sciences, 850 Republican Street, Box 358051, Seattle, WA 98109 0.42 mi
(206) 598-4734(206) 598-4734
ITHS Regulatory Auditing Services aims to provide support to researchers through a pro-active, fr...
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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.