VTR Request Process and Documents

Investigators interested in using the SEER-Linked VTR Program to acquire de-identified, linked tissue, clinical data, pathology reports, and/or digital whole slide images (WSIs) are required to complete the following submission process (Figure 1).

Figure 1: How to submit a request to the SEER-Linked VTR Program
steps to submit request
  1. Study Information Form (F1): The investigator completes and submits the online Study Information Form (F1), which is automatically transmitted to NCI VTR Program Staff.
  2. VTR Program Review Panel: meets to decide if study is approved, conditionally approved pending further information, or declined. If the proposed study is approved, one of the registries will be assigned as the VTR Primary Contact Registry (PCR). NCI will inform investigator about the review outcome through a VTR Review Panel Outcome Letter sent via an email from nciseervtrrequest@mail.nih.gov.
  3. Initial Consultation about Request: The VTR Primary Contact Registry (PCR) will meet with the investigator to advise them on study design and to answer questions.
  4. Study Request Form (F2): After the initial consultation with the PCR, the investigator downloads and completes the PDF Study Request Form (F2), and submits the completed form to NCI VTR Program Staff via email to nciseervtrrequest@mail.nih.gov.
  5. Case Counts, Budget, and Timeline Estimates: After receiving the Study Request Form (F2), the PCR will establish the criteria to search their databases for eligible cancer cases. They will determine estimated case counts by sex and/or race/ethnicity, costs, and timeline for fulfillment of the request.
  6. Letter of VTR Services Available: The investigator will receive a letter from NCI VTR Program Staff with estimates of available cases, costs, and timeline for fulfillment. This letter may be included in funding applications.
  7. Project Documentation: After the investigator obtains funding for the proposed project, they notify NCI Program Staff of funding received and submit project documentation outlined below via email to NCI VTR Program Staff at nciseervtrrequest@mail.nih.gov.
  8. Fulfillment Stage: The registry or registries acquire, process, and send de-identified, linked data and/or tissue to the investigator.

Investigator Responsibilities

Institutional Review Board (IRB): The SEER-Linked VTR Program requires investigators to obtain IRB review and approval (if deemed necessary) before receiving specimens and/or data for their research or other project.

Data Sharing Plan: If the investigator's project is funded by the National Institutes of Health (NIH), the investigator must generate and submit a Data Sharing Plan to comply with the NIH Data Management and Sharing Policy.

Securing funding: The investigator is responsible for securing funding and providing the NCI VTR Program Staff with documentation that funding was awarded for the project.

Institutional Certification: If the request is for tissue that will be used for sequencing studies, then the investigator must have their institution sign an Institutional Certification and must comply with the NIH Data Management and Sharing Policy as noted above.

Authentication and Authorization: The VTR Program is using the general SEER Data Request System for Research Plus data to authenticate and authorize each investigator who participates in the study. In this process, the investigator will be required to acknowledge by initialing four data agreements and limitations documents.

  • SEER Research Data Use Agreement
  • SEER Treatment Data Limitations
  • Best Practices Assurance
  • National Childhood Cancer Registry (NCCR) Data Use Agreement

What Should Investigators Do after Funding Has Been Secured?

After funding has been secured and the investigator has received the Letter of VTR Services Available and determination of approval or exemption by their Institutional Review Board (IRB), they should notify the NCI VTR Program Staff via email at nciseervtrrequest@mail.nih.gov.

Investigators will then be asked to submit the following documents:

  • Updated contact information
  • Copy of the IRB letter of approval or exemption
  • Project funding award amount and start, and end dates
  • Confirmation that financial agreements with the registry or registries have been fully executed
    • Kentucky Cancer Registry
    • Louisiana Tumor Registry
  • Signed Material Transfer Agreement for each registry sending de-identified tissue

Before the investigator can access the de-identified data, tissue, pathology reports, and/or whole slide images (WSIs), they will also need to do the following:

  • Complete the authentication and authorization process for access to SEER data and acknowledge agreements as detailed above
  • Provide an email from the SEER Data Request System showing that access has been granted to the SEER Research Plus Data

Changes to Study Information and/or Request

If the details of the study and/or request have changed since case counts, budget, and timeline estimates were provided, investigators should submit a new Study Information Form (F1) and download, complete, and submit the Study Request Form (F2) to NCI VTR Program Staff via email at nciseervtrrequest@mail.nih.gov. After the financial agreements have been signed, no changes may be made to the request.

For additional information, please see the FAQs.