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 3 Work performed under CMS Contract #HHSM-500-2013-00166C
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 DataUseAgreement@cms.hhs.gov notifying them of the change. 5 Work performed under CMS Contract #HHSM-500-2013-00166C
6 Work performed under CMS Contract #HHSM-500-2013-00166C
DUA Extensions 7 Work performed under CMS Contract #HHSM-500-2013-00166C
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 DataUseAgreement@cms.hhs.gov 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 11 Work performed under CMS Contract #HHSM-500-2013-00166C
12 Work performed under CMS Contract #HHSM-500-2013-00166C
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 DataUseAgreement@cms.hhs.gov 13 Work performed under CMS Contract #HHSM-500-2013-00166C
New File or Year Additions 14 Work performed under CMS Contract #HHSM-500-2013-00166C
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 Gino.Sisti@cms.hhs.gov 6. Executive summary – Only needed to provide justification for new file (research requests only) 16 Work performed under CMS Contract #HHSM-500-2013-00166C
Update DUA Only add new year or files to update DUA. 17 Work performed under CMS Contract #HHSM-500-2013-00166C
18 Work performed under CMS Contract #HHSM-500-2013-00166C
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 19 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Management Plan Changes (Research DUAs only) 20 Work performed under CMS Contract #HHSM-500-2013-00166C
Data Management Plan Changes Research DUAs only 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 21 Work performed under CMS Contract #HHSM-500-2013-00166C
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 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 Research DUAs only 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. 24 Work performed under CMS Contract #HHSM-500-2013-00166C
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 25 Work performed under CMS Contract #HHSM-500-2013-00166C
Summary of Where Changes Go Directl ctly to ResDAC 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 26 Work performed under CMS Contract #HHSM-500-2013-00166C
Resources for Help ResDAC Assistance Desk ˗ Email: resdac@umn.edu ˗ Phone: 1-888-973-7322 ˗ Web: http://www.resdac.org 27 Work performed under CMS Contract #HHSM-500-2013-00166C
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