N3C Cancer Enclave - For Participants

This Enclave has limited funding. Initial participating sites and investigators are being chosen by the scientific leads of the National Cancer Institute (NCI). Domain-specific enclaves like Cancer and Renal are governed by data contributors. Other investigators who wish to participate still have the opportunity if their institution becomes a data contributor. please visit the (N3C Cancer Enclave home page)[url] for further information.

Availability and Funding

The Cancer Enclave is currently expected to be available through September 2026, with extensions subject to continued support and demand. This project is supported by the Office of the Secretary Patient-Centered Outcome Research Trust Fund.

Data streams

N3C ingests and harmonizes data from multiple sources for use in multiple enclaves. These data streams primarily include EHR data harmonized to the OMOP Common Data Model, but may also include data from other sources.

The following data streams are available in the Cancer Enclave:

  • N3C Clinical Harmonized OMOP Patient Data
    • The Cancer Enclave includes a cancer-relevant subset of patients from this data stream according to the following criteria: The enclave includes all patients with evidence of cancer, but will not contain cancer-free controls.
  • External Datasets
    • These include publicly-available data from the US Census, FDA, and other sources.
      • Requesting or Contributing External Data
        • Researchers may request ingestion of additional external datasets; for details on the request and approval process see the page on data streams.
  • Linked Datasets
    • SEER
    • Other data such as claims, mortality, or other registries may be linked in the future.

Data Access For Participating Researchers

Participating researchers wishing to access data within the Cancer Enclave must:

  1. Have their institution sign the N3C Clinical Data Use Agreement, which enables N3C registration and access to Cancer Enclave resources within the platform. Check the N3C Clinical Data Use Agreement to see if your institution has already signed the DUA, and instructions if not.
  2. Register for N3C to log in to the platform.
  3. Apply to an existing Data Use Request (DUR) within the platform as a collaborator. Note that researchers who are not from an institution that is contributing data to the enclave must obtain unanimous consent from contributing organizations in order to participate.

Data Use Request (DUR) Submission Guide

Projects in the Cancer Enclave will be designated by the scientific leads from the data providers and funding agencies. The governance process associated with DUR creation is currently being developed. Anticipated projects will focus on investigating differences among sites and patients in terms of (1) outcomes and (2) treatment practice patterns.

Requirements for request submission also include:

  • Attestation of IT Security and Information Training, available here.
  • Attestation of Human Subjects Research Protection training in the past three years, with a supplied date of most recent completion (Note that N3C does not specify this specific training requirement; you should follow the guidance of your home institution).
  • Attestation and Agreement to the N3C Clinical Data Use Agreement, the N3C Download Policy, and the N3C Code of Conduct.

Time Limits and Renewals: Data Use Requests for the Cancer Enclave are valid for 1 year and renewable for continued access to approved project workspaces.

Special Considerations

While N3C supports multi-institutional collaborative research, researchers are required to protect patient privacy. All collaborators working via video conference must have approved access to all data or results shown. N3C also prohibits taking screenshots or video recordings of data or results, except for aggregated results and summaries that have been approved for export as described in the N3C Download Policy.

Institutional Review Board (IRB)

Institutions who wish to transfer data to the N3C Clinical Enclave are required to have Institutional Review Board (IRB) approval to do so. Johns Hopkins Medicine (JHM) serves as the central IRB for the study, and sites may opt to become a reliance site on the JHM central IRB application.

Sites may alternatively pursue local IRB approval from their own institution’s IRB if they do not wish to become reliance sites, although sites will be required to provide a copy of their local IRB’s approval or exemption letter to the JHM team.

Sites can contact Jessica Mitchell (jmitch59@jh.edu at JHM to initiate the IRB reliance process, or to obtain documentation to pursue local approval from their own institution’s IRB.

In addition to obtaining IRB approval, sites will also need to complete a Data Transfer Agreement with NCATS before being greenlit to transfer data to the N3C Clinical Enclave.

Contacts

List of contacts

  • Links to NCI website
  • ASPE website with a brief description of the cancer enclave project is available at: https://aspe.hhs.gov/capturing-full-trajectory-patient-centered-cancer-care-enhanced-data-linkages

To Cite the N3C: "The analyses described in this [publication/report/presentation] were conducted with data or tools accessed through the NCATS N3C Data Enclave https://covid.clinicalcohort.org and N3C Attribution & Publication Policy v 1.2-2020-08-25b supported by NCATS Contract No. 75N95023D00001 and [insert additional funding agencies or sources and reference numbers as declared by the contributors in their form response above]. This research was possible because of the patients whose information is included within the data and the organizations (https://ncats.nih.gov/n3c/resources/data-contribution/data-transfer-agreement-signatories) and scientists who have contributed to the on-going development of this community resource [https://doi.org/10.1093/jamia/ocaa196]."

For publication submission information, please see the Publication Review Page

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