Institution Essentials

Data Enclave Contribution
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Data Transfer Agreement (DTA)
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IRB Documents
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Data Contribution FAQs
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OMOP Common Data Specifications
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Communications Guidance
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Data Use Agreement (DUA)
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Join the Effort

Help support the national response to COVID-19 and provide researchers with the data they need to answer the most pressing clinical questions.

Institutions can support the work of N3C by becoming a clinical data partner or by facilitating N3C Data Enclave access for their members by executing a DUA with NCATS. You do not need to contribute data to submit a DUA. For more information and steps on how to complete these processes, please see below. If you experience difficulty with any of these steps, please visit the N3C Support Desk.

Data Enclave Contribution Process:

step 1

Step 1: Register to become a member of N3C/CD2Hto obtain access to meetings invitations, documents, discussion channels, and mailing lists.

step 2

Step 2: Data Transfer Agreement

The Data Transfer Agreement (DTA) is a legal document that covers the terms of the transfer of data to N3C. This agreement covers the disclosure of a limited dataset from the contributing site and is signed by the transferring institution’s legal signatory and NCATS. For questions about executing the DTA, contact NCATSPartnerships@mail.nih.gov.

step 3

Step 3: IRB Submission & Approval

IRB approval is required to transfer a limited dataset to the N3C Data Enclave. The Johns Hopkins Medicine IRB serves as the central reviewing IRB that provides oversight of the transfer of data from your organization in accordance with the approved N3C protocol. If you choose to undergo review with your local IRB, a copy of your site’s approval letter must be submitted to Tricia Francis before moving forward.

This initial IRB approval is intended to cover only the contribution of data to N3C and does not cover research using N3C data. When both the DTA and IRB process is complete, you will receive an email notifying when you can transfer your data (see the NCATS FAQ under Contribute Data). For questions regarding N3C IRB requirements, please contact Tricia Francis.

Other IRB Documents:

NOTE: Execution of the DTA and IRB approval are both required before submitting data to the N3C Data Enclave. Once they are in place, N3C will offer a “white glove” service to assist with the data exchange process.

step 4

Step 4: Data Transfer and Acquisition Process

  • Data Acquisition: Emily Pfaff at University of North Carolina, Chapel Hill will assist with the data transfer process. Once information is gathered from your organization, a script will be sent for pulling data in your site’s common data model format (PCORnet, OMOP, ACT, or TriNetX). Phenotype and Data Acquisition Office Hours are available for questions and discussion.
  • Secure File Transfer Protocol (SFTP): After the steps above are complete, an SFTP site will be set up for your organization to both receive the data and have data quality checks performed by the Harmonization team.
  • The average interval for data transfer is once a week; however, your organization can work with the N3C data transfer team to determine what works best for you.