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You've received CMS approval for the project and now you can begin work using the data. See information below for situations requiring an update to your Data Use Agreement (DUA) also known as an amendment.

Change individuals listed on the Data Use Agreement (DUA)

If you need to add or update contact information for an individual from an organization not currently listed on the DUA, then the amendment is submitted to ResDAC.

The documents needed are:

If you need to add, remove or update contact information for an individual within your organization or another organization already included on the DUA, then the change can be sent directly to CMS. Follow the instructions found on the Contact Changes page of the CMS website.

 

Change the data management plan

Any change to the Data Management Plan (DMP) requires CMS review and approval. Only after the review process and subsequent approval from CMS should these updates be implemented. 

This amendment is submitted to ResDAC and requires the following documents.

Change the study cohort, aims, or link to other files

If you need to make changes to the description of the study, such as the study cohort, aims, or the files that are linked to the CMS data, you need to submit the proposed changes for CMS approval. You must describe the proposed changes and explain why the changes fit within the context of the original approved study.

This amendment is submitted to ResDAC and requires the following documents.

The amendment may also require the following materials if it involves requesting additional data.

Change VRDC seat access

If you access data through the Virtual Research Data Center (VRDC) and need to change the seat access, you need to submit the amendment to ResDAC.

Transferring a 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:

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

This amendment is submitted to ResDAC and requires the following documents.

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

This is submitted to ResDAC and requires the following documents.

Add new years or files

Adding the latest year of data to an existing project
You may need to add the latest year of data available to continue your research.

This type of amendment is submitted to ResDAC and requires the following documents.

Adding new files not previously requested
If you need a data file that you did not request in the original DUA application, then you also need to revise the approved Executive Summary to explain why this new file is needed.

Extend the project

CMS Data Use Agreements are effective for one year. Each year, the Requestor or Custodian must email CMS an extension request. Extension requests should be sent directly to CMS. Instructions can be found on the CMS Extensions and Closures website.

Disseminate findings

The CMS Data Use Agreement (DUA) Section 9 outlines how findings may be disseminated. CMS's cell suppression policy allows CMS data users to present summarized findings where all cells contain counts greater than 10.

Excerpt from Section 9 of the DUA:

"The User agrees not to disclose direct findings, listings, or information derived from the file(s) specified in section 5, with or without direct identifiers, if such findings, listings, or information can, by themselves or in combination with other data, be used to deduce an individual's identity. Examples of such data elements include, but are not limited to geographic location, age if >89, sex, diagnosis and procedure, admission/discharge data(s), or date of death.

The User agrees that any use of CMS data in the creation of any document (manuscript, table, chart, study, report, etc.) concerning the purpose specified in section 4 (regardless of whether the report or other writing expressly refers to such purpose, to CMS, or to the files specified in section 5 or any data derived from such files) must adhere to CMS' current cell suppression policy. This policy stipulates that no cell (e.g. admittances, discharges, patients, services) 10 or less may be displayed. Also, no use of percentages or other mathematical formulas may be used if they result in the display of a cell 10 or less."

Resource: CMS Cell Size Suppression Policy

Close the project

At the end of the project, the Requestor must close the Data Use Agreement and identify the disposition of the data files. Closure requests are sent directly to CMS. Instructions can be found on the Extensions and Closures page of the CMS website.