Making Changes to an Approved DUA Work performed under CMS Contract - - PowerPoint PPT Presentation

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Making Changes to an Approved DUA Work performed under CMS Contract - - PowerPoint PPT Presentation

Oct 26, 2022 117 likes •390 views

Making Changes to an Approved DUA Work performed under CMS Contract #HHSM-500-2013-00166C Overview Making updates and changes to an approved DUA Research and Healthcare Operations Contact Changes Extensions Closures New Year or

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Making Changes to an Approved DUA

Work performed under CMS Contract #HHSM-500-2013-00166C

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Overview

  • Making updates and changes to an approved DUA

Research and Healthcare Operations

˗ Contact Changes ˗ Extensions ˗ Closures ˗ New Year or File Additions

  • Research requests only

˗ Data Management Plan Changes ˗ Project Aim Changes

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Contact Changes

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Contact Changes-www.cms.gov

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Contact Changes

Add or Remove Individuals on the DUA

  • Requestor or custodian on DUA generates email

˗ Reference your DUA number. ˗ Include the list of individual(s) you wish to add/remove. ˗ If adding an individual, have the individual complete and sign the signature addendum to the DUA. Attach this to the email.

  • Forward to CMS Project Officer
  • CMS Project Officer will forward to

DataUseAgreement@cms.hhs.gov notifying them of the change.

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Work performed under CMS Contract #HHSM-500-2013-00166C

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DUA Extensions

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Work performed under CMS Contract #HHSM-500-2013-00166C

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DUA Extensions

  • CMS will send out an email 60 and 30

days from the DUA expiration date.

  • CMS emails the User, Custodian, and up to

5 other individuals that are listed on the DUA.

  • CMS Project Officer will forward extension

request to DataUseAgreement@cms.hhs.gov

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Work performed under CMS Contract #HHSM-500-2013-00166C

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DUA Extensions

  • Generate a reply from the extension notice.

˗ Send extension request to CMS Project Officer. ˗ CC the requestor and all custodians.

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Work performed under CMS Contract #HHSM-500-2013-00166C

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DUA Closures

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Work performed under CMS Contract #HHSM-500-2013-00166C

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DUA Closure

  • When all work on the project has been

completed, the DUA should be closed.

  • Requestor should request closure.
  • Complete Certificate of Disposition attesting that

all data, analytical files have been destroyed. ˗ http://www.cms.gov/Medicare/CMS- Forms/CMS- Forms/downloads//cms10252.pdf

  • Requestor emails closure request and Certificate
  • f Disposition to DataUseAgreement@cms.hhs.gov

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Work performed under CMS Contract #HHSM-500-2013-00166C

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New File or Year Additions

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Work performed under CMS Contract #HHSM-500-2013-00166C

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New File or Year Additions

  • Requestor will need to submit an

amendment/update to add new years of data to the DUA.

  • Only need to add the years or files that are not

currently listed.

  • If adding a new file that hasn’t been requested

previously,

˗ Research requests will need to include justification for new file/s within the executive summary ˗ Healthcare Operations DUA request will add justification on the spec worksheet

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Work performed under CMS Contract #HHSM-500-2013-00166C

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New File or Year Additions

  • Request should include:
  • 1. Request Letter
  • 2. Update DUA – Only need to include the new

year(s) or file(s) that are being added.

  • 3. Specifications Worksheet
  • 4. ResDAC will provide an Information Only No Fee

Cost Invoice

  • 5. Email of support from CMS Project contact,

Gino Sisti Gino.Sisti@cms.hhs.gov

  • 6. Executive summary –Only needed to provide

justification for new file (research requests only)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Update DUA

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Only add new year or files to update DUA.

Work performed under CMS Contract #HHSM-500-2013-00166C

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Work performed under CMS Contract #HHSM-500-2013-00166C

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New File or Year Additions

  • Forward draft to resdac@umn.edu for

review.

  • ResDAC Technical Advisor will review and

return comments.

  • Requestor should return finals to ResDAC
  • ResDAC forwards to

Datauseagreement@cms.hhs.gov

  • Privacy will forward to CMS PO
  • CMS PO forwards to GDIT for processing

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Data Management Plan Changes (Research DUAs only)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Data Management Plan Changes

  • Request will be coordinated through

ResDAC.

  • Request should include:
  • 1. Request Letter – Describes the nature of the

change

  • 2. Executive Summary– Description of the

new/changed data management plan

  • 3. Email of support from CMS Project contact,

Gino Sisti Gino.Sisti@cms.hhs.gov

Research DUAs only

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Data Management Plan Changes

  • Forward draft to resdac@umn.edu for review.
  • ResDAC will forward to GDIT for DMP review.
  • GDIT will return DMP review to ResDAC and

requestor.

  • ResDAC will forward to

Datauseagreement@cms.hhs.gov

  • Privacy will send requestor decision

notification

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Project Aim Changes (Research DUAs only)

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Project Aim Changes

  • Request will be coordinated through ResDAC.
  • This is not common.
  • Request should include:
  • 1. Request letter – describes nature of request
  • 2. Executive Summary– Provide original Exec

summary and indicate the changes requested and why the changes are necessary.

  • 3. CMS contact, Gino Sisti email of support.

Research DUAs only

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Project Aim Changes

  • Forward draft to resdac@umn.edu for

review.

  • ResDAC will review and return comments

to requestor.

  • Requestor should return finals to ResDAC
  • ResDAC will forward to

˗ Datauseagreement@cms.hhs.gov

  • Privacy will send requestor a decision

notification

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Work performed under CMS Contract #HHSM-500-2013-00166C

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Summary of Where Changes Go

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ResDAC Directl ctly to CMS

Contact changes X Extension request X DUA Closure X Adding new years or files X Change in Data Management Plan X Change in Project Aims X

Work performed under CMS Contract #HHSM-500-2013-00166C

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Resources for Help

  • ResDAC Assistance Desk

˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org

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Work performed under CMS Contract #HHSM-500-2013-00166C