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NCATS has provided the FDA with access to the N3C Data Enclave. FDA investigators interested in accessing N3C COVID-19 data must complete appropriate human subjects and NIH security training, review and abide by NCATS technology transfer requirements, and submit a Data Use Request (DUR) detailing their proposed project and use of N3C data.
For details on how FDA investigators can access the N3C Data Enclave, please email N3C@fda.hhs.gov.