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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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Institute of Translational Health Sciences, 850 Republican Street, Box 358051, Seattle, WA 98109 0.42 mi
(206) 598-4734(206) 598-4734
Our research bioethics consultants offer advice to researchers, research staff, personnel involve...
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IIC, UW SLU, 815 Mercer Seattle, WA 98109 0.42 mi
(206) 221-5275(206) 221-5275
The overall goals of the IIC are to provide state-of-the-art flow cytometry analysis of the cellu...
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Institute of Translational Health Sciences, 850 Republican Street, Box 358051, Seattle, WA 98109 0.42 mi
(206) 221-1234(206) 221-1234
ITHS offers a variety of biomedical informatics services, including electronic medical record dat...
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P.O. Box 19024, E1-415 Seattle, WA 98109 0.43 mi
(206) 667-4645(206) 667-4645
Specimen Processing/Research Cell Bank provides a broad range of services including processing of...
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P.O. Box 19024, B1-010 Seattle, WA 98109 0.43 mi
(206) 667-4314(206) 667-4314
The Arnold Library provides high quality, responsive services and resources in support of Fred Hu...
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P.O. Box 19024, DE-512 Seattle, WA 98109 0.43 mi
(206) 667-4205(206) 667-4205
Scientific Imaging serves as a centralized facility for imaging and visualization. The resource p...
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P.O. Box 19024, DE-690 Seattle, WA 98109 0.43 mi
(206) 667-6195(206) 667-6195
Flow Cytometry offers a wide range of instrumentation, from single-laser benchtop analyzers to co...
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PO Box 19024, DE-360 Seattle, Washington 98109 0.43 mi
(206) 667-6166(206) 667-6166
The Experimental Histopathology Shared Resource provides a broad range of histology, histochemist...
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P.O. Box 19024, J3-317 Seattle, WA 98109 0.43 mi
(206) 667-5879(206) 667-5879
This resource provides space for freezers used to store research samples, offers assistance with ...
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P.O. Box 19024, DE-352 Seattle, WA 98109 0.43 mi
(206) 667-1051(206) 667-1051
The Proteomics Resource provides support for characterizing proteins and peptides by mass spectro...
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P.O. Box 19024, DE-550 Seattle, WA 98109 0.43 mi
(206) 667-6455(206) 667-6455
The Immune Monitoring Lab provides investigators with services and expertise for studies of cellu...
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P.O. Box 19024, DE-740 Seattle, WA 98109 0.43 mi
(206) 667-2714(206) 667-2714
The Genomics Shared Resource provides expertise to support the generation of genomics-based data....
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1100 Fairview Ave N ME-B143, Arnold Building Seattle, WA 98109 United States 0.47 mi
(206) 667-4639(206) 667-4639
The Fred Hutch Prevention Center is a state-of-the-art exercise facility, nutrition laboratory an...
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Thomas Building, 1100 Fairview Ave N, Seattle, WA 98109 0.48 mi
(206) 667-4289(206) 667-4289
Electron Microscopy provides transmission electron microscopy and scanning electron microscopy fo...
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Fred Hutchinson Cancer Research Center, Thomas Building DE-740 0.48 mi
(206) 667-2714(206) 667-2714
The Bioinformatics Resource (formerly the Computational Biology Resource) is comprised of staff w...
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CCTR, 2001 8th Ave, Suite 400, Seattle, WA 98121 0.58 mi
The Center for Clinical and Translational Research is located at Seattle Children’s Hospita...
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Seattle Children's Research Institute, 2001 8th Ave, Seattle, WA 98121 0.58 mi
(206) 884-7541(206) 884-7541
The primary goal of the Cystic Fibrosis Research and Translation Center (CFRTC) is to be a world ...
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2001 8th Ave., Suite 400, Seattle, WA 98121 0.58 mi
At Seattle Children’s Core for Biomedical Statistics (CCBS), our mission is to provide expe...
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High Throughput Genomics Center, WTC East Suite 600, 2211 Elliot Ave, Seattle, WA, 98121 0.58 mi
(206) 267-1095(206) 267-1095
High-Throughput Sequencing Solutions is a non-profit, auxiliary enterprise administered by the Un...
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Flow Cytometry Core Facility, Seattle Children's, 1900 9th Ave, Seattle, WA 98101 0.6 mi
(206) 884-7382(206) 884-7382
The Flow Cytometry Core at Seattle Children’s Research Institute provides access to state-o...
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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.