National COVID Cohort Collaborative Data Enclave

The National COVID Cohort Collaborative (N3C) Data Enclave is a secure platform through which harmonized clinical data provided by our contributing members are stored. The enclave includes demographic and clinical characteristics of patients who have been tested for or diagnosed with COVID-19, and further information about the strategies and outcomes of treatments for those suspected or confirmed to have the virus.

Mission: To highlight CTR involvement with the National COVID Cohort Collaborative (N3C), to entice and promote junior investigators to learn to utilize the N3C with a mentor and provide resources for using the N3C data enclave.

Navigators by CTR

Each CTR has a N3C Navigator to assist researchers with the creation of N3C enclave accounts, Data Use Request (DUR) submissions, and other administrative clinical needs. If you have questions or need assistance, contact your CTR’s N3C Navigator from the table below.

SiteInvestigator NavigatorEmail
CAMCMary Emmettmary.emmett@camc.org
DESuzanne McCahansuzanne.mccahan@nemours.org
LABrian Melanconbrian.melancon@pbrc.edu
MEIvette Emeryivette.emery@mainehealth.org
NECarol Gearycarolr.geary@unmc.edu
RIKaren Crowleyn3c-ri@brown.edu
WVSharon Patrickpatricks@hsc.wvu.edu
PRMary Helen Mays Serpanmary.mays@upr.edu
VTJonathan Emeryjonathan.f.emery@uvm.edu

Getting Onboarded to N3C

Create Enclave account
  1. Confirm your institution has a Data Use Access (DUA)
    • An N3C Data Use Agreement (DUA) is executed by National Center for Advancing Translational Sciences (NCATS) and a research institution (or directly with a researcher in the case of a citizen scientist who is not affiliated with an institution). To submit a DUA to NCATS, institutions can download the N3C DUA form and email it to NCATS Partnerships.
      Note: DUAs can only be signed by Authorized Institutional Officials who have the authority to bind all users at their institution to the terms of the DUA. With the exception of citizen scientists not associated with institutions, individual researchers cannot sign their own DUAs with NCATS.
  2. Use your institutional email related to the DUA.
  3. ORCiD is required.
  4. Complete NIH security training.
  5. Connect with a CTR N3C Investigator Navigator.

Option 1) Create a new project: Connect with a CTR N3C Investigator Navigator

  1. Confirm with your local Institutional Review Board (IRB) for policies related to data levels.
  2. Log in to the enclave.
    • You will need the date of your Human Subjects Protection Training (i.e., CITI Training) completion.
  3. Click “Data Use Request (DUR)” as shown below:
  1. Click “Create a New Project.”
  2. Once you create a new project, you will be asked if you want to allow others to join the project OR if you prefer to not have collaborators at this step (as shown below). You will be able to change this later.
  1. You can add collaborators to your project in this phase. You will need the collaborators’ emails in order to add them to the project.
  2. Complete all the required attestations.

Option 2) Join an Existing Project

  1. Confirm with local Institutional Review Board (IRB) for policies related to data levels.
  2.  Log in to the enclave.
    • You will need the date of your Human Subjects Protection Training (i.e., CITI Training) completion.
  3. Click “Data Use Request (DUR)” as shown below:
  1. Click the button requesting to become a collaborator (as shown below).
  1. Search for the project by the name of the Principal Investigator (PI) or title of the project.
  2. When you’ve found the project, click the button “Request to Join” (as shown below).
  • If the project is using limited data sets (LDS), you will need to have local Institutional Review Board (IRB) approval and/or follow your local Institutional Review Board (IRB) approval process.
  • You will receive a notification from N3C once approval has been granted. After approval, please allow approximately 5 (five) days for a workspace to be provisioned.

CTR-Led Data Use Requests (Projects)

Data Use Requests (DURs) are what a researcher will submit in the enclave to gain access to a data workspace.

A Data Use Request (DUR) is an online application submitted by the researcher within the N3C Data Enclave that describes the scope and nature of the project and justifies the requested data access tier. Approval of the DUR by the Data Access Committee (DAC) is required before a researcher can access data within the enclave. (Approved DURs are valid for 1 year.) The following steps outline the process for a researcher to either submit a DUR for a new project or join an existing project.

Domain Teams

A Domain Team is where a researcher will attend meetings with clinicians that are in the same clinical domain or expertise.

N3C Domain Teams enable researchers with shared interests to analyze data within the N3C Data Enclave and collaborate more efficiently in a team science environment. These teams provide an opportunity to collect pilot data for grant submissions, train algorithms on larger datasets, inform clinical trial design, learn how to use tools for large scale COVID-19 data, and validate results. Domain Teams are enabled by Slack channels for discussion, meetings, and document management and are supported by N3C workstreams. N3C encourages researchers of all levels to join a Domain Team that represents their interests or to suggest new clinical areas to explore. A Domain Team can submit one or more research projects, but collaboration is encouraged for similar concepts.

CTR Domain Teams

Cardiovascular Diseases: The mission of the Cardiovascular Disease Clinical Domain Team is to better understand the effects of COVID-19 on patients with new and existing cardiovascular disease including, but not limited to, acute myocardial infarction, congestive heart failure, stroke, and coronary artery disease to determine the effect of COVID-19 on outcomes including mortality, hospitalization, and access to care.

Cardiothoracic and Vascular Surgery: The Cardiothoracic and Vascular Surgery Domain Team seeks to establish risk factors for morbidity and mortality in COVID-19 patients who underwent cardiothoracic surgical procedures.

GIS and Spatial Epidemiology: The mission of the GIS and Spatial Epidemiology (GSE) Domain will be to facilitate the technical implementation of basic and advanced GIS and spatial statistical methods within the National COVID Cohort Collaborative database. Our group will also provide expertise to other domains interested in applying spatial statistical or epidemiological methods within the scope of their work.

Immunosuppressed or Comprised (ISC): The Immunosuppressed/Compromised (ISC) Clinical Domain Team aims to gain a better understanding of how COVID-19 affects patient populations with suppressed or compromised immune systems. The initial research will focus on a subset of target populations, including persons with HIV, solid organ transplant patients, and patients with autoimmune disorders, including skin diseases such as atopic dermatitis and eczema. The team will also identify areas of research for the ISC populations that will require additional in-depth study at a level that the N3C data may not be able to provide. Through this research, a better understanding will be gained for how various types, levels, and durations of immunosuppression or compromise contribute towards ISC patient outcomes upon COVID-19 infection. Team meetings are held on the 1st Friday of the month at 8:00am PT/11:00am ET. Register for meetings here. Join the Team! The Immunosuppressed/Compromised (ISC) Domain Team is comprised of several self-organizing subdomain teams that lead research in their specific specialties and projects. These teams focus on researching the impact of COVID-19 on particular subsets of the ISC population. For more information on the ISC Domain Team, their work within the N3C Data Enclave, and their associated subdomain teams, view the recorded ISC presentations.

Lifespan Disabilities: The mission of the Lifespan Disabilities Domain Team is to advance practices and policies that improve the education, access, and health of all people with developmental and other disabilities, as well as their families, by examining extent to which individuals with disabilities have been affected by COVID-19 diagnoses and access to appropriate treatments and follow up.

Pediatric: The Pediatrics Clinical Domain Team aims to study the unique impact of COVID-19 on children from birth to young adulthood.

Perioperative: The Perioperative Domain Team is focused on understanding the impact of COVID-19 on the treatment and outcomes of surgical patients. The domain team’s goal is to better understand the role COVID-19 plays in relation to the management of surgical patients. The Perioperative Domain Team seeks to develop evidence that is directly relevant to the perioperative surgical complications post-COVID diagnosis. This information may provide surgical teams a better understanding of the associated risks and implement plans that improve surgical outcomes.

Rural Health: The Rural Health Domain Team seeks to understand the epidemiology, utilization, treatment, and outcomes of the COVID-19 pandemic in rural communities. The overarching goal is to develop better evidence for potential differences in the COVID-19 epidemic response and outcomes for rural health care centers and rural dwellers. Studying the at-risk populations and unique challenges faced by rural communities during and after the pandemic may provide opportunities for improving rural health and health care.

Additional Information

N3C Engagement

IDeA-CTR N3C Investigator Engagement Event: Jumpstarting Access to Clinical Data for COVID-19 Research (held Thursday, February 17, 2022 2:00 – 5:00 p.m.)

This event introduced IDeA-CTR investigators to the National COVID Cohort Collaborative (N3C). The N3C Data Enclave is a secure platform through which harmonized clinical data provided by our contributing members are stored. The Enclave includes demographic and clinical characteristics of patients who have been tested for or diagnosed with COVID-19, and further information about the strategies and outcomes of treatments for those suspected or confirmed to have the virus.

2:00-5:00pm ESTFull EventBrief Program
Full Program
Full Recording
Master Slides
2:00-2:30pm ESTOpening Remarks
Welcome
Sally Hodder, MD (WV-CTR)
Clifford Rosen, MD (NNE-CTR)
Michele McGuirl, PhD (NIGMS)
Recording
Slides
2:30-3:30pm ESTCTR N3C Research Studies
Vignettes from Across the CTR Network
 
What is the Best Therapy for COVID-19?
J. Zachary Porterfield, MD, PhD (UK); Bradley S. Price, PhD (WV-CTR)
 
Association of Vitamin D Prescribing and Clinical Outcomes in Adults Hospitalized with COVID-19
Kimberly Murray, MPP (NNE-CTR)
 
Higher Hospitalization and Mortality Rates among SARS-CoV-2 Infected Persons in Rural America
Jerrod Anzalone, MS (GP-CTR)
Recording
3:30-4:15pm ESTKeynote
The National COVID Cohort Collaborative (N3C): A Social Experiment in Collaborative Research
Christopher Chute, MD, DrPH (N3C Co-PI)
Recording
Slides
4:15-4:45pm ESTOrientation
Getting Started with N3C
Shawn O’Neil, PhD, MS (N3C Training Coordinator)
Recording
Slides
4:45-5:00pm ESTClosing Remarks
Navigating N3C at Your IDeA-CTR Site
Sharon Patrick, MS, MPA, CPCS (WV-CTR); Elizabeth Chen, PhD (RI-CTR)
Recording
Slides

** Reminder: Do not share enclave data with others who do not have enclave access. Also, screenshots of the data within the enclave are not permitted.