Tips for Completing the Data Use Agreement and Signature Addendum

Tips for Completing the Data Use Agreement and Signature Addendum

Current Version Date: 
03/02/2012

Data Use Agreement (CMS-R-0235)

Note: These instructions apply to form CMS-R-0235. This form should be used when applying for CMS identifiable data where a new Data Use Agreement (DUA) is required or when adding Part D data to an existing DUA for the first time. Those who are looking to update an existing DUA should use form CMS-R-0235U.

Also, all sections requiring signature (sections 16, 17, and 19) MUST be submitted with all blocks complete (i.e., email address, phone number, etc.).  CMS can now accept pdf versions of the DUA.

DUA #

The DUA form includes an empty box in the upper right hand corner of the form. If you are applying for a new DUA either through the purchase of new data OR reuse, you will leave this box empty. However, if you are applying for an amendment to an existing DUA that involves adding Part D data for the first time, please enter your DUA number here.  Reuse requests should not list the reuse DUA number here as you will be assigned a new DUA number for your study.

DUA # section of the DUA

 

Section 1 – Requestor

List the requesting organization on these two lines.

Important: If you are funded by an external entity (versus internal funding), the organization listed as the awardee must be the Requestor. Sub-contractors may not submit the request as Requestor/User, but may sign as the Custodian of the data.

Requesting Organization section of the DUA

 

NOTE: Only the requesting organization may be allowed to request reuse of the data listed on this DUA in the future.

Section 4 – Name of Study/Project

The name of the study should match the study title listed on the other documents included with your request packet.  The CMS Contract No. (if applicable) line should not be completed.

Section 5 – Data Files

List all files you are requesting in this section. Leave the System of Record column blank. If your request involves the reuse of data, please list separately from new use, if applicable, and specify the DUA number under which you will request reuse. You may list multiple files on the same row if the years are the same and there are not enough rows. Please specify whether your request is for a 5% sample, 100% file, or a cohort. Please list beginning and ending year(s). If you are requesting a crosswalk file, please list the year the crosswalk file is being outputted. Only currently available files and years can be listed on the DUA.

Data Files section of the DUA

 

Section 6 – Retention Date

The retention date should be listed as a complete date (MM/DD/YYYY). The retention date can be no more than 1 year from the time of your request. (If after 1 year, your study is not completed, you may at that time apply for an extension to your DUA.)

 

Section 12 – Attachments

If you are including a signature addendum (CMS-R-0235A), please list that here. If not, please leave blank. You do not need to list all the documents included in your request packet. Please see instructions later in this document to determine if you need to submit a signature addendum.

 Attachments section of the DUA

 

Section 16 – User

This section will be signed by an individual who has legal authority to sign on behalf of the requesting organization. Often the Principal Investigator of the study will sign, however some organizations have a designated legal representative sign as User. Researchers should check with their organization to determine who is best to sign.

Important: The individual signing as the User should also be the person who signs the request letter included with your request packet.

NOTE:  Only the person who signs as User can provide required letters of support for any future reuse requests of this data. Furthermore, only individuals from the requesting organization may be allowed to request reuse of the data listed on this DUA.

Section 17 – Custodian

This section will be completed and signed by the individual responsible for the observance of all conditions of user and for data security at the institution where the data will be held.

Section 18 – Disclosure Provision

This section will be completed by a CMS representative and should be left blank.

Section 19 – Federal agency

If your study protocol is federally approved, you will need to have your federal project officer complete and sign this section. If your protocol is not federally approved, please leave blank.

Section 20 – CMS representative

This section will be completed by a CMS representative and should be left blank.

Article Number: 
154
Author(s): 
This work was performed under CMS Contract Number HHSM-500-2005-00027I.
Related Data Request Processes: