The N3C Data Enclave is Open for Research!

The National Center for Advancing Translational Sciences (NCATS) and the National Center for Data to Health (CD2H) announce the launch of the National COVID Cohort Collaborative (N3C) Data Enclave. NIH also made a news release on Wednesday September 2, 2020. Faced with the urgent need to address the global pandemic, subject matter experts from the Clinical and Translational Science Awards (CTSA) Program, Observational Health Data Sciences and Informatics (OHDSI), PCORnet, the Accrual to Clinical Trials (ACT) Network, and TriNetX came together to create the N3C in an effort to overcome technical, regulatory, policy, and governance nuances for sharing and harmonizing individual-level, clinical data about the novel coronavirus.

The goal of the N3C is to systematically collect, harmonize, and make available patient data from healthcare providers nationwide to accelerate advances in COVID-19 clinical care. The needs brought about by the COVID-19 pandemic have presented an opportunity to leverage a framework of CD2H tools and resources, NCATS cloud resources, and collaborative informatics networks that had already been established throughout the CTSA Program. 

The N3C was launched in just a few short months and is a testament to the dedication of the informatics community to fight the pandemic. Currently, the N3C Data Enclave contains clinical data from the electronic health records of over 374,000 patients. This number is expected to grow rapidly given the 57 organizations that have signed agreements to contribute data. Attribution for collaborative efforts is key to N3C’s philosophy of supporting rapid, robust, and reproducible results and is carried out through the Enclave’s graph-based tracking and reporting method. The first manuscript that covers the methods for building the Enclave: The National COVD Cohort Collaborative (N3): Rationale, Design, Infrastructure, and Deployment is currently in press at JAMIA with almost 200 authors.

With 6 workstreams, 4 subgroups, and 20 clinical task teams (to date), the N3C is composed of a diverse group of community experts. The Johns Hopkins Medicine Institutional Review Board (IRB) serves as the central IRB for this multi-site, collaborative research initiative; however, institutions may choose to undergo local review with their home IRB. (The N3C IRB approved protocol and other IRB documents can be viewed here.) Dashboards and N3C project lists are currently being created to allow for collaboration and engagement. A Support Desk has also been established to assist users every step of the way, and Office Hours are available to address questions in real time.

To use the N3C Data Enclave, users can follow the instructions located on the N3C website. The N3C Data Access Committee (DAC) reviews research project requests to ensure compliance and COVID-19 relevance. Approved requests are effective for one year from the date access is granted and are renewable. Frequently asked questions are also available to assist with data access and use on the N3C website and governance on the NCATS N3C webpage. 

To assist with N3C messaging for CTSA hub social media and other promotions, NCATS has created an N3C CTSA Program Stakeholder Toolkit containing multimedia specifically for the N3C Data Enclave launch, and an N3C Communications Guidance packet with ongoing support for press releases, presentations, and webpages. (Both available soon.) N3C currently has a Newsletter Template for Organizations and a Webpage Builder for Organizations available to assist with engagement and outreach for both the CTSA and other types of organizations. 

Please join the N3C in this unified partnership among a diverse group of clinicians, researchers, and data scientists to speed COVID-19 research, identify treatments and specialized care needs, and reduce the immediate and long-term impacts of the disease. For more information, access the National COVID Cohort Collaborative (N3C) website and the National Center for Advancing Translational Sciences (NCATS) N3C webpage.

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