Announcement of the National COVID Cohort Collaborative (N3C) to CTSA PIs

Dear CTSA PIs, 

I am happy to announce that the National COVID Cohort Collaborative (N3C) Data Enclave opened its doors to the research community last week. You will hear more about this in the coming days, and more information is available on the NCATS and CD2H websites.

Since March, the CD2H and the CTSA community have worked tirelessly with NCATS to stand up this secure enclave of harmonized medical record data from people who were tested for COVID-19 across the country. Although the N3C Data Enclave is not yet at full capacity, it will offer a wealth of information to study the disease, explore potentially effective treatments and gain insights into fighting its after-effects. We encourage researchers who will request access to or who will work within the enclave to assemble collaborative teams that have expertise in a variety of areas (e.g., clinical research, statistical analysis, informatics) to make the best use of the N3C data and analytics capabilities. 

The N3C is a massive team effort, and we should all be proud of collectively stepping forward to fill a critical gap of information needed in such short order. CD2H has galvanized an entire community to address the multitude of issues surrounding data acquisition, harmonization, and analytics. We have nearly the entire CTSA consortium signed on to contribute data to the N3C Data Enclave, and several institutions have already begun the process of signing Data Use Agreements that will enable their researchers to request access to the data. NCATS has built a secure environment for housing and protecting the data while also making sure that the data will be available to the larger biomedical research community.

We have launched the N3C Data Enclave as efficiently as possible, while taking significant steps to protect its extremely important information. As such, we have put the following security measures in place:

• Data in the enclave: Data are received as a Limited Data Set (LDS) that includes only two of the 18 Health Insurance Portability and Accountability Act (HIPAA) defined elements: patient zip code and dates of service. NCATS has executed nearly 60 Data Transfer Agreements with institutions willing to contribute data to the enclave.
• Secure environment: The data reside and remain in the NCATS environment. Approved users can analyze data only within the platform. All data are encrypted both in transit and at rest, without exception. The platform software includes several data and information protection functionalities to comply with regulations and industry requirements, such as HIPAA, Federal Information Security Management Act, International Security Management Association, California Consumer Privacy Act, Criminal Justice Information Services, Department of Defense, Impact Level 4 and General Data Protection Regulation.
• Levels of data access: Through a Data Use Request, the N3C will provide access to different levels of data—an algorithmically derived “synthetic” data set, a de-identified data set from the LDS that excludes the two HIPAA elements, or the LDS itself. An Institutional Review Board determination is required to access the LDS.
• Data Access Committee: The N3C Data Access Committee consists of federal staff who will consider all N3C Data Use Requests and ensure that the research is COVID-specific, that relevant training or local oversight is in place, and that the level of access requested is appropriate for the proposed research project objectives.
• Commitment to continual monitoring of the N3C Data Enclave security and human subject protections measures: NCATS and the N3C community will continually monitor the data and human subjections protections for the enclave and will adjust or augment them as needed.

I am grateful for your partnership in making the N3C possible and marshalling our resources and expertise to help overcome the unprecedented global pandemic of COVID-19.  

Best wishes, 

Chris