Making Changes to an Approved Study

When an organization needs to make a change to an approved study, it is called an amendment.

The most common types of amendments and the documents needed are listed below. If you wish to make a change that is not listed below, please contact ResDAC for assistance.

Adding New Years or Files

Adding the latest year of data to an existing project
Often researchers need to add the latest year of data available to continue their research.

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

  • RIF Request Letter Template for Amendment
  • RIF Specifications Worksheet
  • Update to Existing Data Use Agreement
  • Additional Supporting Materials (if applicable)

Adding new files not previously requested
If a researcher finds that a data file is needed that he/she did not request on their original DUA application, then the researcher needs to also revise the approved Executive Summary to explain why this new file is needed.

  • Revised Executive Summary

Changing the Data Management Plan

Researchers making a change to the Data Management Plan (DMP) should submit the revisions for review. 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.

  • RIF Request Letter Template for Amendment
  • Revised Executive Summary
  • Amendment Letter of Support from Federal Project Officer (if applicable)

Changing the Study Cohort, Aims or Linking to Other Files

Researchers making changes to the description of the study, such as the study cohort, aims, or the files that are linked to the CMS data, need to submit the proposed changes for CMS approval. The researcher must describe the proposed changes and explain why the changes fit within the context of the original approved study within the last submitted Executive Summary.

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

  • RIF Request Letter Template for Amendment
  • Revised Executive Summary
  • Amendment Letter of Support from Federal Project Officer (if applicable)

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

  • RIF Specifications Worksheet
  • Update to Existing Data Use Agreement
  • Additional Supporting Materials (if applicable)

Changing VRDC Seat Access

Researchers accessing data through the Virtual Research Data Center (VRDC) may need to make changes to the seat access.  All of the following changes are submitted through ResDAC.

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

 The documents needed are:

  • RIF Request Letter Template for Amendment
  • Signature Addendum to DUA
  • Amendment Letter of Support from Federal Project Officer (if applicable)

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.

  • RIF Request Letter Template for Amendment
  • RIF Specifications Worksheet
  • Amendment Letter of Support from Federal Project Officer (if applicable)

Changing Individuals Listed on the Data Use Agreement (DUA)

If a researcher is adding or updating 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:

  • RIF Request Letter Template for Amendment
  • Revised Executive Summary
     - Revised Data Management Plan
     - Collaborator Checklist
  • Signature Addendum to DUA
  • Amendment Letter of Support from Federal Project Officer (if applicable)

If a researcher is adding, removing or updating contact information for an individual within his/her organization, and/or another organization already included on the DUA, then the change can be sent directly to CMS. Follow the instructions found on the CMS Contact Changes website.

Extending or Closing the Project

Extending 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.

Closing 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 CMS Extensions and Closures website.

To begin the request process, email the following materials in their original format (.xls, .pdf, .doc) to resdac@umn.edu.

Required Materials