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Making Changes to an Approved DUA Work performed under CMS Contract #HHSM-500-2013-00166C
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 File Additions
Research requests only
˗ Data Management Plan Changes
˗ Project Aim Changes
2 Work performed under CMS Contract #HHSM-500-2013-00166C
Contact Changes
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Contact Changes-www.cms.gov
4 Work performed under CMS Contract #HHSM-500-2013-00166C
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
[email protected] notifying them of
the change.
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Work performed under CMS Contract #HHSM-500-2013-00166C
6 Work performed under CMS Contract #HHSM-500-2013-00166C
DUA Extensions
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8 Work performed under CMS Contract #HHSM-500-2013-00166C
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 [email protected]
9 Work performed under CMS Contract #HHSM-500-2013-00166C
DUA Extensions
Generate a reply from the extension notice.
˗ Send extension request to CMS Project Officer.
˗ CC the requestor and all custodians.
10 Work performed under CMS Contract #HHSM-500-2013-00166C
DUA Closures
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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 of Disposition to [email protected]
13 Work performed under CMS Contract #HHSM-500-2013-00166C
New File or Year Additions
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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
15 Work performed under CMS Contract #HHSM-500-2013-00166C
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 [email protected]
6. Executive summary –Only needed to provide justification for new file (research requests only)
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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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New File or Year Additions
Forward draft to [email protected] for review.
ResDAC Technical Advisor will review and return comments.
Requestor should return finals to ResDAC
ResDAC forwards to [email protected]
Privacy will forward to CMS PO
CMS PO forwards to GDIT for processing
19 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Management Plan Changes (Research DUAs only)
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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 [email protected]
Research DUAs only
21 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Management Plan Changes
Forward draft to [email protected] for review.
ResDAC will forward to GDIT for DMP review.
GDIT will return DMP review to ResDAC and
requestor.
ResDAC will forward to [email protected]
Privacy will send requestor decision
notification
22 Work performed under CMS Contract #HHSM-500-2013-00166C
Project Aim Changes (Research DUAs only)
23 Work performed under CMS Contract #HHSM-500-2013-00166C
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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Project Aim Changes
Forward draft to [email protected] for review.
ResDAC will review and return comments to requestor.
Requestor should return finals to ResDAC
ResDAC will forward to
Privacy will send requestor a decision notification
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Summary of Where Changes Go
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ResDAC Directly 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
Resources for Help
ResDAC Assistance Desk
˗ Email: [email protected]
˗ Phone: 1-888-973-7322
˗ Web: http://www.resdac.org
27 Work performed under CMS Contract #HHSM-500-2013-00166C
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