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  • Financial Interest Disclosure System User Guide | Research Tools
    FIDS to create and maintain your SFI disclosures Overview and Navigation Start the Disclosure Process Significant Financial Interest SFI Profile Disclosure Types Select eGC1 Enter Other Activity Indicate SFI Add or Edit SFI Enter Significant Financial Interest Complete a Disclosure with SFI Disclosure Complete Disclosure Review Statuses Edit a Disclosure Delete SFI Add Additional Sponsored Research FIDS Just In Time Email Notifications Annual Updates Email Notifications Details and Samples next

    Original URL path: http://www.washington.edu/research/tools/systems/fids/support/guide (2014-06-24)
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  • Human Subjects Division - Documents
    Home Browse A Z Documents 1113 HSD Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Related Topics Clinical Trials Cancer Consortium IRB at the Fred Hutchinson Cancer Research Center Western Institutional Review Board WIRB Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1113 Last Updated 05 25 2012 Version 3 00 Filesize 831 5 KB Audiences HSD Staff IRB Member Researcher Doc Type Policy ClinicalTrials gov Instructions for Registering Your Trials Purpose This document outlines the steps for registering a clinical trial with ClinicalTrials gov Related Documents Clinical Trials gov Instructions for Responsible Party and Releasing a Study Record ClinicalTrials gov Instructions for Updating a Study Record Every 6 Months ClinicalTrials gov Q A for Registering Studies ClinicalTrials gov

    Original URL path: http://www.washington.edu/research/hsd/docs/1113 (2014-06-24)
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  • Human Subjects Division - Documents
    UW Medicine Compliance Research Excellence Energy at UW eScience Guides Clinical Trials Handbook Grants gov Submission Guide Researcher s Guide You are here HSD Home Browse A Z Documents 1077 HSD Home Training Training HSD Training Videos Training Options to Meet Requirements Verification Report Browse A Z Forms Policies Procedures and Guidance Topics Glossary Contact HSD Contact HSD Directions to HSD Documents Document Update Schedule HSD posts updated documents to the web site on the last Friday of each month In rare cases due to an urgent need an updated document will be posted during the month HSD and the IRB ask that researchers make every effort to use the most recent document version Questions about a specific document version Contact hsdforms uw edu Document Details Download Document 1077 Last Updated 06 09 2014 Version 1 10 Filesize 48 5 KB Audiences HSD Staff IRB Member Researcher Doc Type E C Material UW Fee for Industry Studies Purpose This document describes why the Human Subjects Division HSD is raising its fee for industry sponsored clinical trials from 1000 to 1500 effective with all contracts finalized on or after September 1 2010 Change Notes Related to Ver 1 10 noted 06

    Original URL path: http://www.washington.edu/research/hsd/docs/1077 (2014-06-24)
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  • GIM 13 - F&A Rate & Base Table
    66 MTDC Through 06 30 2010 FY 2010 68 MTDC 07 01 2010 06 30 2011 FY 2011 72 MTDC 07 01 2011 06 30 2012 FY 2012 73 MTDC 07 01 2012 06 30 2013 FY 2013 74 MTDC 07 01 2013 06 30 2014 FY 2014 Other Sponsored Activity 33 8 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Instruction 53 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Industry Sponsored Clinical Trial 1 27 TDC 10 01 2011 09 30 2014 Research Affiliate Program 20 TDC 01 01 2010 12 30 2014 ON CAMPUS 4333 Brooklyn Ave NE Box 359472 Seattle WA 98195 9472 Organized Research 54 MTDC 07 01 2009 06 30 2012 FY 2010 FY 2012 54 5 MTDC 07 01 2012 06 30 2014 FY 2013 FY 2014 Other Sponsored Activity 33 8 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Instruction 53 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Industry Sponsored Clinical Trial 1 27 TDC 10 01 2011 09 30 2014 Research Affiliate Program 20 TDC 01 01 2010 12 30 2014 OFF CAMPUS Actual performance site location and Seattle Cancer Care Alliance SCCA Organized Research 26 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Other Sponsored Activity 26 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Instruction 26 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014 Industry Sponsored Clinical Trial 1 27 TDC 10 01 2011 09 30 2014 Research Affiliate Program 20 TDC 01 01 2010 12 30 2014 PRIMATE CENTER Washington National Primate Center Box 357330 Seattle WA 98195 7330 Organized Research Primate Center Core 42 MTDC 07 01 2009 06 30 2014 FY 2010 FY 2014

    Original URL path: http://www.washington.edu/research/osp/gim/gim13a.html (2014-06-24)
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  • Human Subjects Division - Topics
    excluded from the research and any treatment associated with the research if relevant that the research subject s access rights are to be suspended while the clinical trial is in progress and that the right to access PHI will be reinstated at the conclusion of the clinical trial Blanket authorizations for research to be conducted in the future are not permitted Each new use requires a specific authorization What is needed to request a Waiver of HIPAA Authorization The UW IRB Committees use specific criteria in reviewing requests for a waiver of HIPAA authorization for research In completing the Human Subjects Review Application UW 13 11 researchers should explain how The use or disclosure of protected health information involves no more than minimal risk to the privacy safety and welfare of the individual The research could not practicably be conducted without the waiver or alteration The research could not practicably be conducted without access to the protected health information There is an adequate plan to protect the identifiers from improper use or disclosure There is an adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law and There are adequate written assurances that the protected health information will not be re used or disclosed to a third party except as required by law for authorized oversight of the research or as permitted by an authorization signed by the research subject In requesting this waiver researchers should also provide the following information Detailed information about the types of protected health information that will be used including how it will be used who will have access to it and when it will be destroyed What risks are posed by the use of the data and how they have been minimized The justification for access to the data and why they are necessary to conduct the research What should my consent form contain Guidance is available regarding consent including sample forms on the Consent Assent and Waivers topic page Who should be listed on consent forms The principal investigator should always be identified on the consent form Also listed should be the name and phone number of the contact person for research subjects No matching topics found Everything Documents Keywords All Topics Tasks Audiences 0 9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z A About HSD About the IRB Adverse Events and Unanticipated Problems Air Force alteration annual review Apply for Review Approaching and Recruiting Prospective Subjects Approaching and Recruiting Prospective Subjects Advertisements Approaching and Recruiting Prospective Subjects Intermediaries Approaching and Recruiting Prospective Subjects Pre Screening Records Approaching and Recruiting Prospective Subjects Screening Approaching and Recruiting Prospective Subjects Telephone Approaching and Recruiting Prospective Subjects Web Based approval Approval in Principle Army assurance information B Biological Specimens C Cancer

    Original URL path: http://www.washington.edu/research/hsd/topics/Western+IRB+%28WIRB%29 (2014-06-24)
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  • Office of Research Information Services - Grant Runner
    Campus and OSP can watch the submission process go from OSP to Grants gov to NIH in real time on the eApprovals History and Comments page Kim Littlefield OSP Administrator Upcoming Learning Opportunities Class Title When SAGE 101 Creating and Submitting eGC1s July 1 2014 1 00pm 4 00pm More Learning Opportunities Grant Runner the first UW integration with Grants gov combines the eGC1 and sponsor forms for some funding opportunities NIH R01s R03s and R21s with modular budgets With the click of a button OSP can electronically submit your application via Grants gov to the sponsor Many US Research institutes are already using this system to system technology to submit applications and retrieve status information via Grants gov As of July 2013 the UW has successfully submitted more than 1 380 applications to Grants gov using Grant Runner What You Gain You no longer have to download and fill out the Adobe forms from Grants gov you can complete the SF424 directly in SAGE Grant Runner pre populates UW institutional codes and some eGC1 information for you in your SF424 Grant Runner automatically checks for common SF424 errors and validates that required fields are complete You can view Grants gov tracking number and NIH status directly in your eGC1 s History and Comments When You Can Use It The sponsor is NIH National Institutes of Health SF424 is required Your application has a modular budget under 250 000 and Your application funding opportunity is a R01 R03 or R21 Grant Runner Support for New Form C NIH is transitioning to an updated form set with a Competition ID of FORMS C The new form set is available on Grant Runner and is required for all applications due on or after September 25 2013 Some opportunities may allow the use

    Original URL path: http://www.washington.edu/research/main.php?page=orisGR (2014-06-24)
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  • Office of Sponsored Programs - Working with Industry
    Income Procedures Gifts vs Sponsored Projects Concurrence Letter New Budget Setup Budget Extension Research Performance Progress Report RPPR Forms Learning Learning Acronyms and Abbreviations Faculty Orientation to Research Faculty Development Series Policy Procedures Guidance Policy Procedures Guidance Export Compliance Outgoing Subcontracts Small Business Subcontracting Plan Preparation Instructions SBIR and STTR Programs NIH Designation of Multiple PIs Joint Agreements Contact OSP Contact OSP Directions to OSP Select a Topic Clinical Trials Cost Sharing Export Compliance Grants gov Applications Joint Agreements and Outgoing Subcontracts Working with Industry Working with Industry Search Industry Related Offices at the UW UW Center for Commercialization UW Center for Commercialization Digital Ventures UW Center for Commercialization Invention Licensing Contact Info for Working with Industry Michael A Corn 206 616 2585 Associate Director Office of Sponsored Programs Box 359472 University investigators enter into many types of research relationships with industry These relationships are governed by agreements made between the university and the company Agreements are legal contracts that define each party s rights and obligations in the relationship The UW offers our collaborators research expertise licensing opportunities access to facilities and more We are committed to fostering mutually beneficial relationships with our partners in business and industry Read more Guidance for Industry Projects Industry Sponsored Research Agreements cover research of mutual interest to a UW investigator and a company and which the sponsoring company funds in whole or in part Guide to Research Agreements with Industrial Sponsors Research Agreement Sample SBIRs and STTRs The federal government mandates that many federal agencies must commit certain percentages of their funding to the Small Business Innovation Research SBIR Program and the Small Business Technology Transfer STTR Program SBIR STTR grants often involve subcontracts to universities to conduct a portion of the research SBIR STTR subcontracts are established according to procedures and

    Original URL path: http://www.washington.edu/research/main.php?page=industryAgreements (2014-06-24)
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  • GIM 3 - Employee Benefit Costs Under Sponsored Projects
    benefit rates associated with an employee s effort and salary on a sponsored project are to be included in proposed sponsored project budgets consistent with OMB Circular A 21 and specific sponsor policies All sponsored project proposal budgets should include funding for employee benefits at rates commensurate with the salary object code of the individuals participating on the project as set out in the fringe benefit rate table Publication of the preliminary fringe benefit rates is for use in multi year proposal budgets It is recommended that preliminary rates be used to calculate anticipated fringe benefit costs in the fiscal year s beyond the current fiscal year for which the University has approved rates Actual fringe benefit rates charged to a sponsored project will reflect the current approved rates for that fiscal year Procedures and Guidance Fringe benefit rates table Benefit rates and separation leave Historical Fringe Benefit Rates Responsibilities Academic Unit eGC1 reviewers Review sponsored project budget for consistency with local policies and this GIM Office of Sponsored Programs Review sponsored project budget presented in eGC1 and proposal for consistency with each other and for correct application of fringe benefit rates as set out in this GIM Communication with Sponsor as needed for clarification of effective date of rates and application of rates Principal Investigator or his her delegate Prepare sponsored project budget consistent with OMB Circular A 21 and this policy with respect to University employee costs Definitions Preliminary Rates Calculated rates based on estimated costs for charging fringe benefit costs to budgets during the upcoming fiscal year These are the rates that have been or will be submitted to the Department of Health and Human Services Division of Cost Allocation for approval Separation Leave Qualifying payments made to benefits eligible employees for accumulated annual leave at the

    Original URL path: http://www.washington.edu/research/osp/gim/gim3.html (2014-06-24)
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