After your project is approved and you've received your data, you will need to communicate with CMS from time to time to update them on the status of the project. See information below for situations requiring an update to your project and how to handle them.
Change the requester on the DUA
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.
If the only change you are making is to change the requester on a DUA, the change can be sent directly to CMS. Follow the instructions found on the Contact Changes page of the CMS website.
If you are making additional changes to your DUA (e.g., also adding new data files), you will submit an amendment to ResDAC. The documents needed are:
Change the data custodian
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 data_privacy_safeguard_program@mbltechnologies.com. If you have not yet transitioned to a DMP SAQ, contact ResDAC for guidance.
Add a collaborating organization to the DUA
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.
Add/update/remove additional contacts on the DUA
An additional contact is an additional individual (who isn't a requester or custodian) who should receive notifications about the DUA and will be able to perform certain DUA functions. If you need to add, remove or update contact information for an additional contact, 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 Self-Attestation Questionnaire (DMP SAQ)
Changes to your DMP SAQ need to be approved by CMS prior to being implemented. Contact the Data Privacy Safeguard Program (DPSP) team at data_privacy_safeguard_program@mbltechnologies.com for help making changes to your DMP SAQ.
Resource: How to Update the DMP SAQ
Change the study cohort, aims, or link to other files
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:
Manage CCW VRDC access
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:
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:
Adding a CCW VRDC Seat
This amendment involves adding a new seat to an existing DUA.
The documents needed are:
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:
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:
Add new data (new years or files)
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.)
Add or change funding source
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:
Extend the DUA
CMS RIF DUAs are effective for one year. Each year, you 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 under the heading "Extending a Researcher RIF DUA".
Remove a collaborating organization from a DUA
If you need to remove a collaborating organization from your RIF DUA, contact ResDAC for required forms.
Close the DUA
At the end of the project, you must close the DUA and identify how the data files and any associated analytic files were disposed. Instructions can be found on the Extensions and Closures page of the CMS website under the heading "Closing a Researcher RIF DUA". The request to close your DUA or to notify CMS of the disposition of specific files on the DUA, can be sent directly to CMS.
The documents needed are: