Submitting an HCIA Research DUA Request Faith Asper, M.H.S., CIPP/G - - PowerPoint PPT Presentation
Submitting an HCIA Research DUA Request Faith Asper, M.H.S., CIPP/G Director Work performed under CMS Contract #HHSM-500-2013-00166C Overview Describe the request process Provide a detailed review of the required materials for a
Faith Asper, M.H.S., CIPP/G Director
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Resea earcher cher ResDAC CMS GDIT Draft Packet Packet Revisions Reviews Final Packet CMS Analyst Privacy Board Decision Notification DMP Review Processing/ Onboarding
Work performed under CMS Contract #HHSM-500-2013-00166C
Process may take 8-12 weeks CMMI PO identifies as Research
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ResDAC has created a template
a. Physical receipt b. VRDC The Executive Summary is the main document reviewed by the CMS Privacy Board. It includes a Data management plan, which is reviewed by GDIT.
Please supply the proposal that CMS approved.
Please complete the 6-page DUA. DUA Attachment B Acknowledgement that requestor is allowed to identify physicians.
DUA This is needed for individuals that will access the data and are NOT supervised by either the User (#16 of DUA) or Custodian (#17 of DUA). This will also be needed if the VRDC seat holder if he/she did not sign #16 or #17 of the DUA. 6
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Include the CMS grant award face sheet as evidence that this request is an CMMI awardee and therefore, data are free of charge.
Cost Invoice ResDAC will produce an information only, no fee cost invoice so that all individuals involved with the request know that there is no charge for the data and why.
Worksheet This document outlines the data that are requested and where data are to be shipped.
Institutional review board waiver approval is necessary for all research requests.
Document that requests the researcher identify whether the request is being submitted as a Research ch or Health th Care Operati ations ns request. Other file specific materials Examples include: Variable justifications for Part D and Assessment data and Part D DUA Attachment A 7
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This is the Exec Summary used when physical data are requested.
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This is the Exec Summary used when VRDC access is requested.
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CMS will assign after submission This should be the Awardee Organization Name
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Insert a CMS contract No if you have received one. Most requests will not have one.
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Include the name of the project.
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List specific files and years requested. Leave SOR blank. Year for the crosswalk files should be the year that it was provided. (i.e. 2015) CMS has an automatic 1 yr retention period.
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If signature addenda are needed, include that under #12 as well as Attachment A and/or B.
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#16 is the individual that is authorized to sign on behalf of the Requesting Organization. #17 is the individual that is responsible for the data security.
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Must include physical address (No PO Boxes).
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CMMI PO will sign #20 after final package is submitted to CMS.
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Person that signed #16 of DUA should sign here.
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Insert study name as it appears on the DUA. Please select custodian. Must include physical address. Must be physical signature.
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This should be the individual that is knowledgeable about the request. This should be the individual that signed #16 of the DUA.
˗ Name of the IRB ˗ Review data & expiration date ˗ Study title (that matches the study title on DUA) ˗ Principal Investigator name
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File Specific fic Material rials
Justification Please provide the Part D variable justification worksheet that is found within the specifications worksheet.
Attachment A
Justification The Assessment variable justification worksheets are separate Excel spreadsheets found on our website. 27
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Select the variable, provide reason for selection, & risk level.
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Select the variable, provide reason for selection.
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Step 1
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