The DAC is responsible for tracking and documenting all DUA's and supporting IRB certificates issued for any project using data that is housed on the DAC Servers. The DAC Director and the DAC Compliance Coordinator are available to assist investigators with the DUA submission process.
Types of DUA's
The DAC supports the submission of the below types of DUA requests:
New Use DUA:
Required when a researcher purchases new data for a study from CMS.
Required when a researcher plans to reuse existing data approved under another Dartmouth CMS DUA.
Required when a researcher needs to:
- Add new data type
- Add new years of data
- Update Data Management Plan
- Contact changes
- Add/remove study personnel
Required annually, with Federal Project Officer (FPO) approval
Required if user is not requesting an extension, with Federal Project Officer (FPO) approval
Collaborators are organizations beyond the DUA Holder (the funded institution) which are jointly involved in the research study. There are three (3) classifications of collaborators. The applicable classification is determined by the data sharing arrangement for a study.
- Data Custodian – There is an additional organization which will be storing the data for the duration of the study. The DUA Holder for this study will not be storing data on-site.
- Custodial Collaborator – This organization will be storing data on-site. The DUA Holder is also storing data on their site.
- Collaborator – The organization is participating in the study but will not be storing CMS RIF on location. Instead, collaborating researchers will remotely access the data or will travel to the location where the data is being housed by the DUA Holder or Data Custodian.
- If a collaborator is listed on the project staff list but is not accessing CMS RIF and is not a signatory to the DUA a collaborator checklist is still required.
Required Documentation for DUA Collaborators
- Data Custodian - 1) Full DMP; and 2) DUA Holder v. Data Custodian Checklist
- Custodial Collaborator - 1) Full DMP; and 2) Collaborator Checklist
- Collaborator - 1) Collaborator checklist
Things to remember:
- Per CMS, the DUA submission and the IRB titles must match exactly.
- Per CMS, only one DUA may be submitted per project.
- CMS does not permit a researcher to reuse data originally acquired by another organization (cross-institutional reuse).
- If you are collaborating with an institution other than Dartmouth College on a DUA, a Project Specific IRB is required for both institutions.
- Most TDI/DAC investigators are willing to share their DUA's to provide template language upon request.
New and Reuse DUAs:
Please follow these instructions when preparing the study RIF Executive Summary form. The instructions follow each section of the form.
1. Study Overview. Please complete this section with a thorough explanation of the scope of work for your project, which usually encompasses language specific to the research aims and objectives of the grant. Please note that this should be the same scope of work that was submitted in the project review form. Any changes to the scope of work requires an updated project review form approval.
2. Have you ensured that your data request includes the minimum amount of data necessary to achieve your research objectives? List the data necessary to complete the defined scope of work in section 1.
2.1. Please describe how this cohort will meet minimum data necessary. Provide the approximate size of the expected cohort (# of benes) to ensure you won't exceed a 20% sample from the Carrier File.
2.2. List the CMS data files and years being requested at this time and provide justification for how each will be used in the analysis. List all "primary" CMS data (reference DUA 14049) you are requesting and any derivative files (reference the DUA it is currently approved under) you intend to work with).
2.4. Please list any non-identifiable or non-CMS files you are planning to use in conjunction with the above files for your analysis. Please note that the DAC will automatically list other potential files that you will likely need for your study.
3. You are requesting Research Identifiable Files (RIF). Why can't Limited Data Sets (LDS) files be used for this study. Describe why you can only use RIF data to complete the study. For more information, visit ResDAC.
4. Is it feasible to obtain individual level authorization from Medicare/Medicaid beneficiaries for your research? Explain. The DAC will complete this section for you.
5. If you intend on requesting the National Death Index segment of the Master Beneficiary Summary File, please complete the NDI Supplement. Please see the DAC Director if you intend to work with the National Death Index.
Dissemination and Reporting of Findings
Please indicate which journals, presentations, forums, meetings, etc. you intend to disseminate your study findings to. CMS requires specific names, such as JAMA, NEJM, Academy Health, etc.
Send a complete list of who (name & contact info) will be on the project to the DAC Compliance Coordinator. Include anyone working with the data, writing papers with the data, and/or supervising someone who will be working with the data.
Data Management Plan
The DAC will prepare a Data Management Plan and other documents required for DUA submission. Please note that in some instances, further data/variable justification may be required. For example, Part D (prescription drug data) requires specific variable justification.
If you are collaborating with another institution, please contact the DAC Director.
Upon completion of the DUA application and supporting documentation by the DAC and the Principal Investigator, the following process will take place:
- The submission will be sent to ResDac for review;
- ResDAC will review and send the submission to the CMS Privacy Board;
- CMS will approve the DUA (pending payment);
- The DUA will be activated when payment is confirmed to CMS.
The ResDAC CMS DUA Application Approval Processs Timeline typically takes a minimum of 3-5 months from submission to receipt of data.