Data and Safety Monitoring (ITHS)
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
Institute of Translational Health Sciences, 850 Republican Street, Box 358051, Seattle, WA 98109
(206) 598-4734(206) 598-4734
Our research bioethics consultants offer advice to researchers, research staff, personnel involve...
Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101
(206) 287-2900(206) 287-2900
Kaiser Permanente Washington Health Research Institute is a non-proprietary, public-domain resear...
Laboratory for Usability Testing and Evaluation, University of Washington, Seigh Hall, Seattle, WA 98195
LUTE facilities can support a wide range of research methods used across the human centered desig...
McLaughlin Research Institute Animal Resource Center, 1520 23rd St. South, Great Falls, MT 59405
(406) 452-6208(406) 452-6208
The McLaughlin Research Institute Transgenic Facility was established in response to the need for...
Lipid Clinic Northwest, Harborview, 325 9th Ave, Seattle, WA 98104
(206) 520-5000(206) 520-5000
The Lipid Clinic Northwest at Harborview provides care for patients with high cholesterol and blo...
Olympic Natural Resources Center, 1455 S Forks Ave, Forks, WA 98331
(360) 374-3336(360) 374-3336
The University of Washington Olympic Natural Resources Center located on the Olympic Peninsula in...
Pacific Northwest National Laboratory, 902 Battelle Boulevard, Richland, WA 99352
1-888-375-PNNL (7665)1-888-375-PNNL (7665)
Located in Richland, Washington, PNNL is one among ten U.S. Department of Energy (DOE) national l...
Center for Sustainable Forestry at Pack Forest, 9010 453rd Street East, Eatonville, WA 98328
(253) 692-4160(253) 692-4160
The purpose of the center is to discover, teach and demonstrate the concepts of sustainable fores...
Photolithography, Washington Nanofabrication Facility, University of Washington, Seattle, WA 98195
Located in the new Molecular Engineering & Science Building, the Molecular Analysis Facility ...
Physics Instrument (Machine) Shop, University of Washington Department of Physics, 3910 15th Ave. NE, Seattle, WA 98195
Specializing in the manufacture of experimental research and prototype apparatuses, the Physics I...
1100 Fairview Ave N ME-B143, Arnold Building Seattle, WA 98109 United States
The Fred Hutch Prevention Center is a state-of-the-art exercise facility, nutrition laboratory an...
UW Medical Center Radiology/Imaging Services, Department of Radiology, 1959 NE Pacific St., Seattle, WA 98195
(206) 598-6200(206) 598-6200
The Harborview Medical Center PET/CT scanner facility is equipped with a state-of-the-art PET/CT ...
3T Whole-Body MRI, South Lake Union Bio-Medical Imaging Center, Seattle, WA 98109
3T Whole-Body MRI available at UW South Lake Union Bio-Medical Imaging Center.
Research Clinic, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA 98101
The clinic’s facilities and capacity allow GHRI to perform trials of varying size and compl...
Seattle Children’s 70th and Sandpoint Administration Building (Magnuson)
The Research Coordinator Core (RCC) at Seattle Children’s provides clinical research coordinator ...
P.O. Box 19024, J3-317 Seattle, WA 98109
This resource provides space for freezers used to store research samples, offers assistance with ...
Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA 98105
(206) 987-2000(206) 987-2000
Hope. Care. Cure. These three simple words capture what we are here to do. Together, we deliver...
SLU Lab Services, Brotman Building, 815 Republican Street, Seattle, WA 98109
(206) 685-2720(206) 685-2720
The SLU Lab Services is located in Room B56 of the Brotman Building. The center provides a variet...
P.O. Box 19024, E1-415 Seattle, WA 98109
Specimen Processing/Research Cell Bank provides a broad range of services including processing of...
Health Sciences Library, lower level, Room T216 1959 NE Pacific St Seattle, WA 98195 United States
TRAIL is a partnership between the Institute of Translational Health Sciences, the University of ...
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...
IIC, UW SLU, 815 Mercer Seattle, WA 98109 0.42 mi
The overall goals of the IIC are to provide state-of-the-art flow cytometry analysis of the cellu...
Institute of Translational Health Sciences, 850 Republican Street, Box 358051, Seattle, WA 98109 0.42 mi
ITHS offers a variety of biomedical informatics services, including electronic medical record dat...
P.O. Box 19024, E1-415 Seattle, WA 98109 0.43 mi
Specimen Processing/Research Cell Bank provides a broad range of services including processing of...
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...
P.O. Box 19024, DE-512 Seattle, WA 98109 0.43 mi
Scientific Imaging serves as a centralized facility for imaging and visualization. The resource p...
P.O. Box 19024, DE-690 Seattle, WA 98109 0.43 mi
Flow Cytometry offers a wide range of instrumentation, from single-laser benchtop analyzers to co...
PO Box 19024, DE-360 Seattle, Washington 98109 0.43 mi
The Experimental Histopathology Shared Resource provides a broad range of histology, histochemist...
P.O. Box 19024, J3-317 Seattle, WA 98109 0.43 mi
This resource provides space for freezers used to store research samples, offers assistance with ...
P.O. Box 19024, DE-352 Seattle, WA 98109 0.43 mi
The Proteomics Resource provides support for characterizing proteins and peptides by mass spectro...
P.O. Box 19024, DE-550 Seattle, WA 98109 0.43 mi
The Immune Monitoring Lab provides investigators with services and expertise for studies of cellu...
P.O. Box 19024, DE-740 Seattle, WA 98109 0.43 mi
The Genomics Shared Resource provides expertise to support the generation of genomics-based data....
1100 Fairview Ave N ME-B143, Arnold Building Seattle, WA 98109 United States 0.47 mi
The Fred Hutch Prevention Center is a state-of-the-art exercise facility, nutrition laboratory an...
Thomas Building, 1100 Fairview Ave N, Seattle, WA 98109 0.48 mi
Electron Microscopy provides transmission electron microscopy and scanning electron microscopy fo...
Fred Hutch Cancer Center, Thomas Building DE-740 0.48 mi
The Bioinformatics Resource (formerly the Computational Biology Resource) is comprised of staff w...
The Center for Clinical and Translational Research is located at Seattle Children’s Hospita...
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 ...
At Seattle Children’s Core for Biostatistics, Epidemiology and Analytics in Research (BEAR), our ...
High Throughput Genomics Center, WTC East Suite 600, 2211 Elliot Ave, Seattle, WA, 98121 0.58 mi
High-Throughput Sequencing Solutions is a non-profit, auxiliary enterprise administered by the Un...
Flow Cytometry Core Facility, Seattle Children's, 1900 9th Ave, Seattle, WA 98101 0.6 mi
The Flow Cytometry Core at Seattle Children’s Research Institute provides access to state-o...
The 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.