N3C Enclave

The N3C Enclave is Open for Business. Learn How to Gain Access.

The National COVID Cohort Collaborative (N3C) is a partnership among Clinical and Translational Science Awards (CTSA) Program hubs and the National Center for Data to Health (CD2H) with funding and overall stewardship by NCATS. N3C has created a central registry of patients who have been tested for COVID-19 or have a clinical diagnosis of COVID-19. This registry is called the N3C ‘Enclave’ and is now available to the research community to study COVID-19 at a scale and statistical power not possible within any single institution. N3C has assembled a standardized collection of demographics, symptoms, laboratory test results, procedures, medications, medical conditions, physical measurements and other data from hospital electronic health records and health care plans across the country for analysis within an accessible, secure, cloud-based resource. 

About 60 institutions from across the country have agreed to transfer clinical data from individuals tested for COVID-19 and about 20 have already deposited data in the N3C Enclave. MUSC was among the first ten to collaborate and share clinical data.

The N3C Enclave contains data from about 601,000 patients as of September 25, 2020.

Data is available in three different tiers:

  • Synthetic dataset with artificial, anonymous, statistically-comparable, computational derivative of the original data; it does not contain individually identifiable health information, also known as protected health information (PHI) as defined by the Health Insurance Portability and Accountability Act (HIPAA).
  • De-identified dataset with patient data that has been stripped of identifiers as defined in the HIPAA privacy rule “Safe Harbor” method.
  • Limited Data Set with patient data that includes only two of the 18 elements defined as identifiers under the HIPAA privacy rule (full dates and full ZIP codes available).

More Details

N3C Data Access Tiers and Conditions

All tiers require the following:

  • N3C registration
  • N3C Enclave account
  • Data Use Agreement (DUA) executed with NCATS (available for MUSC since August 24, 2020)
  • Information technology security training from NIH
  • Approved Data Use Request (DUR) with justification for data access need

The de-identified and limited datasets access also require human subjects research protection training. The limited data set requires a local IRB determination letter.

More Details for Gaining Access:

  1. Register with N3C and apply for a N3C Data Enclave account. Make sure that you use your MUSC institutional email. You will need an ORCID ID.
  2. Upon approval, you will receive a confirmation email. Follow the email instructions and login to the N3C Enclave. As MUSC employee, you should login with your existing account (i.e., MUSC account). You will be forwarded to the MUSC Shibboleth login and then to the N3C Enclave. You will need to have 2FA setup for your first access (e.g., Google Authenticator, Microsoft Authenticator).
  3. Complete the required IT security training from the NIH (required because the Enclave is a NIH/NCATS resource).
  4. Complete the required human subjects research protection training if not already completed for your research at MUSC and if accessing the de-identified or limited datasets.
  5. Obtain IRB approval from MUSC if accessing the de-identified or limited datasets. N3C data access is study-specific so you will need to submit an IRB for each N3C project in which you plan to participate. IRB application tips and language examples are available here.
    a. For the limited dataset, MUSC requires that researchers submit an application for IRB review as an Exempt determination.
    b. For the de-identified dataset, MUSC highly recommends submitting an IRB application for a Non-Human Subjects Research determination. This determination will aide in publication, as many journals and conferences require documentation of IRB review, and such determination will meet these requirements.
  6. Prepare information to submit a Data Use Request (DUR; template available here). A project title, research project abstract (public) and brief research project rationale will be needed.
  7. Submit the DUR in the Enclave (Create a project or Data menu link). You will need to examine and agree with the N3C Enclave DUA and the Code of Conduct. The IRB approval letter will also be needed if requesting access to the limited dataset.
  8. Your application will then be examined by the N3C Data Access Committee (DAC). Once approved, you will receive a confirmation email. Congratulations! You now have access to clinical data in the N3C Enclave.

Additional Resources:

N3C Registration Checklist

N3C FAQ

N3C Help Desk

N3C Brochure