Managing your project after obtaining the data

CMS must be notified if there is a change in your organization's requester. The requester is the individual authorized to sign agreements on behalf of the requesting organization. This person is often referred to as the ‘legal signatory’. This person accepts all terms and conditions in the DUA and attests that all the information contained in the request is accurate.

Required forms for requester change:

• RIF Data Use Agreement (DUA): Amendment Request
• Key Personnel Supplement

Required forms for update to requester contact information:

• Key Personnel Supplement

Instructions:

The current requester listed on the DUA (or an authorized representative from the requesting organization if the current requester is not longer available) must send an email to resdac@umn.edu with the following information:

1. Email Subject: "Request to [change Requester/update requester contact information] on DUA [your DUA number]"
2. Body of Email: Must include the reason for the change to the requester. Common reasons include: the Requester has taken a different position within the organization or the Requester is no longer associated with the requesting organization.
3. Email Attachment: The signed Amendment form (signed by the new requester, only required for requester change) and completed Key Personnel Supplement (with new/updated requester information)

If you are making additional changes to your DUA (e.g., also adding new data files), you may include the requester change/update requester contact information in the same amendment.

An additional contact is an individual (who is not the requester or data custodian) who should receive notifications about the DUA and will be able to perform certain DUA functions. All DUAs require at least one and no more than three additional contacts. Additional contacts may be changed at any time. If you need to add, remove, or update contact information for an additional contact, the change should be sent directly to ResDAC.

Required forms:

• Key Personnel Supplement

Instructions:

The current requester (or the data custodian/additional contact with the requester CC'd) must send an email to resdac@umn.edu with the following information:

1. Email Subject: "Request to [add/update/remove additional contacts] on DUA [your DUA number]"
2. Email Attachment: The completed Key Personnel Supplement (with new add/update/remove additional contacts)

If the requester is no longer with the organization, the requester needs to be updated on the DUA before an additional contact change can be made.

If you are making additional changes to your DUA (e.g., also adding new data files), you may include the additional contact information change in the same amendment.

For instructions and the required forms, see "Request Submission Instructions: Qualified Entity (QE)".

Changes to your DMP SAQ need to be approved by CMS prior to being implemented. Contact the Data Privacy Safeguard Program (DPSP) team at DPSP@cms.hhs.gov for help making changes to your DMP SAQ.

Resource: How to Update the DMP SAQ

CMS must be notified if there is a change to your data custodian. The data custodian is the individual who will be responsible for ensuring that the environment in which the CMS data is stored complies with all applicable CMS data security requirements, including the establishment and maintenance of security arrangements to prevent unauthorized use. If you have a Data Management Plan Self-Attestation Questionnaire (DMP SAQ), contact the Data Privacy Safeguard Program (DPSP) team at DPSP@cms.hhs.gov. If you have not yet transitioned to a DMP SAQ, contact ResDAC for guidance.

Changes to the description of your study, such as the study cohort, aims, or the files that are linked to the CMS data need to be approved by CMS. These changes require a DUA amendment be submitted to ResDAC.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• Revised RIF Application

You must receive permission from CMS before adding a new collaborating organization to your project. A Collaborating Organization works with the Requesting Organization, is involved in the research, and will be viewing or accessing unaggregated data or results that do not meet the cell suppression policy outlined in section 5 of the CMS DUA. If you need to add a collaborating organization, you will need to submit an amendment to ResDAC.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• Key Personnel Supplement
• Collaborating Organization Supplement
  • If the collaborator will be storing CMS data with small cell sizes onsite, the collaborator will need a DMP SAQ.

Projects based in the Chronic Conditions Warehouse Virtual Research Data Center (CCW VRDC) occasionally need to be adjusted. Amendments need to be submitted if you need to change or extend your seat access, renew your project, increase your storage space, or request any other CCW VRDC add-ons.

Transferring a CCW VRDC Seat
This amendment involves transferring an existing seat to a different person. There is no fee for a seat transfer.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet
• Signature Addendum

Extending an Existing CCW VRDC Seat
CCW VRDC seats are granted for one year and may be renewed annually. Each year the CCW VRDC seat holder will need to renew and pay for his/her seat to continue accessing the data. 

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet

Adding a CCW VRDC Seat
This amendment involves adding a new seat to an existing DUA.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet
• Signature Addendum

Renewing a CCW VRDC Project Fee
DUAs with CCW VRDC access are assessed an annual project fee. Each year the project fee is due on the project renewal date.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet

Adding or renewing CCW VRDC Add-ons
DUAs associated with CCW VRDC access can request add-ons such as additional Databricks credits, additional space, additional output reviews or Stata licenses.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet

If you need to add new years of already approved data files to your DUA or add a data file that you have not been previously approved to access, you will need to submit an amendment request to ResDAC.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request
• RIF Specifications Worksheet or State Specifications Worksheet
• Additional file specific materials (ResDAC can advise if any other materials are needed.)

CMS tracks the type of funding for DUA projects. If federal grant or for-profit funding needs to be added or changed on a DUA, please submit an amendment request to ResDAC.

The documents needed are:

• RIF Data Use Agreement (DUA): Amendment Request

CMS Researcher DUAs are approved for a period of one year. DUAs that are not closed or extended after 30 days of the expiration date are in violation of the terms and conditions of the DUA and will be forced to close and the data destroyed. DUAs may only be extended within 60 calendar days prior to the DUA expiration date.

Reminder: Effective April 24, 2023, requests to extend a Research DUA with physically shipped data require an approved Data Management Plan Self-Attestation Questionnaire (DMP SAQ).

Instructions:

The requester listed on the DUA (or the data custodian/additional contact with the requester CC'd) must send an email to resdac@umn.edu with the following information:

1. Email Subject: "Request to extend DUA [your DUA number]"
2. Email Body: The body of the email should include the following:

• We are still using this data as originally requested for our Project/Study. In accordance with the terms and conditions of the DUA, we understand that the data for this DUA may not be used in any form, or for any additional work, outside the scope of this DUA without the expressed written consent of CMS.
• I have reviewed the contact information on the DUA and submitted necessary updates to resdac@umn.edu for processing.
• We request a one (1) year [or less, if applicable] extension for the DUA number listed in the subject of this email.

If you need to remove a collaborating organization from your RIF DUA, contact ResDAC for required forms.

At the end of the project, you must close the DUA and identify how the data files and any associated analytic files were disposed. The request to close your DUA or to notify CMS of the disposition of specific files on the DUA, should be sent directly to ResDAC.

Required forms:

• Certificate of Disposition (COD)

Note: Only the requester or data custodian may sign the Certificate of Disposition (COD) form to close a DUA. If the requester and data custodian are no longer with the organization, an appropriate contact from the requester's organization may sign the COD and indicate next to the signature that the requester listed on the DUA is no longer associated with the organization(s) listed on this DUA.

Instructions:

The requester listed on the DUA (or the data custodian/additional contact with the requester CC'd) must send an email to resdac@umn.edu with the following information:

1. Email Subject: "Request to close DUA [your DUA number]"
2. Email Attachment: The completed and signed Certificate of Disposition