SEER-Medicaid: Required Documents & Instructions for Submitting Applications

Please be aware that in compliance with CMS, we no longer release SEER-Medicaid data outside the USA.

Instructions for submitting an application

Release of SEER-Medicaid data is project specific. You must have an approved application in order to access these files.

Required information should be provided at SEER-Medicaid request system.

1. Project Description: (DOCX, 30 KB)
   The description of your project must include:
   • statement of main hypothesis/specific research question;
   • description of study subjects and cancer sites/phases to be included in the analysis;
   • brief explanation of how key components of the study will be obtained/identified within the files:
     • cohort selection criteria,
     • covariates, and
     • outcomes;
   • a list of requested files and how each will be used;
   • description of the planned analyses (e.g., logistic regression will be used to assess…);
   • description of the personnel involved;
   • timeline for completion;
   • references can be included, if relevant.
   
   

   Special Variable available: Breast Oncotype DX

   Genomic Health Inc (GHI), which is now part of Exact Sciences Corp., developed the Oncotype DX Breast Recurrence Score® assay (Assay), which is a commercial diagnostic test that predicts 10-year distant recurrence risk based on the expression of 21 genes. The resulting recurrence score is used to better weigh the harms and benefits of chemotherapy, thereby informing treatment decisions. The Assay data are linked to SEER data via a collaboration between NCI and GHI, with IMS acting as the third party, honest broker. The Assay variables that have been linked to SEER data include: Assay, Assay risk group, Assay reason no score, Assay test report date, and Assay months since diagnosis. Note: Per the agreement with GHI, NCI all approved applications requesting Oncotype Dx variables and any manuscripts or reports that result from the analyses of such data will be shared with GHI. These documents will be shared with GHI for informational purposed only; all approval decisions will be handled by NCI.

   *NOTE: variation in multigene signature method have been observed (e.g., by geographic region and calendar year); this variation should be taken into consideration during study design and interpretation.

   Please note: No investigator can request the entire database.

2. Data Storage and Protection Plan: (DOCX, 17 KB)
   The preferred method of data storage is on an institutional server with all the protections that provides. If you are choosing an alternate data storage method, please provide the rationale as to why you made that choice. Please be aware that Cloud Storage of data does NOT meet privacy rules and will not be approved for storing SEER-Medicaid data. This descript must include:
   • the specific location of the data and where/how the data will be stored
   • details on how the data will be protected from unauthorized access
   • information on the storage/protection of the media you receive containing the original files
   • assurances that no attempt will be made to identify individual patients, hospitals or physicians
   • assurances that publications and presentations of the data will not allow identification of patients, hospitals or physicians
3. SEER-Medicaid Data Use Agreement (DUA) (PDF, 149 KB)
   This document lists the terms the investigator must agree to in order to receive access to the SEER-Medicaid linked data. Principal Investigators are responsible for monitoring / controlling all access to the SEER-Medicaid linked data In the case of students and fellows, the department chair or advisor from the student's academic institution must sign the DUA and submit the application as the Principal Investigator.
   
   The Principal Investigator should have all staff that will access these files sign the DUA for their records. If other personnel (e.g. IT staff) will be supervising the storage of the data, they must sign a CUSTODIAN DUA, which is available from the SEER-Medicaid contact.
   
   Cloud Storage services do not meet privacy rules and are not acceptable for the storage of SEER-Medicaid data.
4. Institutional Review Board (IRB) approval
   Please provide documentation of the determination of the Institutional Review Board (IRB) of your local institution. The title on the IRB approval must correspond with the title on the SEER-Medicaid data request. For more information, please see IRB approval and HIPAA Regulations.
5. Funder letter (if applicable)
   If your organization is a consulting firm, contractor, or pharmaceutical company, or your project is funded by one of these entities, your application must include information about the funding source. The application packet must include a letter from the funder indicating that you are free to work and publish your findings without limitations by the funder. This letter must be on company letterhead.

All requests for SEER-Medicaid data must be reviewed and approved before any data can be purchased.

NOTE: There is increased interest in using SEER-Medicaid data for mapping of cancer incidence, treatment, and survival. If you plan to map data at any resolution or report on only one registry or state, please state this clearly in your proposal application. NCI is committed to protecting the privacy of the SEER registries, the hospitals and physicians, and, ultimately, the patients represented in the data. Requests to present data for a single registry must be approved by the Principal Investigator for that registry.

SEER Registries

NCI supports the SEER registries in their use of SEER-Medicaid data for registry-conducted projects. Registry-conducted projects include use of SEER-Medicaid data to assess the completeness of registry data or research analyses conducted by registry staff. NCI will provide data for registry-conducted projects without charge for up to 4 projects per year. This includes requests for updated data. Data released for registry-conducted projects should be maintained on the registry's institutional computer systems. Researchers from SEER registries who are requesting SEER-Medicaid data as part of funded research, such as grants and contracts, will be required to reimburse IMS for the cost of acquiring the SEER-Medicaid data.

SEER Investigators must submit:

1. A letter from the SEER Principal Investigator for that registry stating that this is a registry-conducted project and that he/she is a collaborator on the project.
2. Project description for incorporation into a master file of projects.
3. Data storage and protection plan.
4. A completed and signed SEER-Medicaid Data Use Agreement (PDF, 149 KB).

Approval & Processing Time

Applications for SEER-Medicaid linked data are reviewed by two separate groups, consecutively. The initial review team may provide questions /comments on the project, which will require a response and revision by the investigator. Once the initial review team is satisfied with the application, it is sent to the second review team. This process can take at least 6 – 8 weeks.

When the application is fully approved, IMS (NCI's programming contractor) will contact investigators to ensure they obtain all the data files needed for the analysis. Omissions and errors in ordering files are the responsibility of the investigator.

Preparing the data requires 2-4 weeks from receipt of payment, depending on the number of requests in the queue. See Cost of Acquiring SEER-Medicaid Data for information about the fees charged to cover the cost of creating the data files.

Changes to Previously Approved Applications

Any change to a previous approved application must be approved before any work can begin. Please use the change form (DOCX, 14 KB) to request approval for any change, including changes in data storage

.