Institution Essentials

Data Enclave Contribution

Data Transfer Agreement (DTA) Extension

IRB Documents

Data Contribution FAQs

OMOP Common Data Specifications

Communications Guidance

Data Use Agreement (DUA) Extension

Renew your Institution's Participation

NCATS is extending the period to continue site data contributions and data use for N3C COVID. The current Data Transfer Agreements (DTAs) and Data Use Agreements (DUAs) are ending.

Institutions that want to continue participating in N3C will have to sign and execute the extension agreements with NIH.

Learn More HERE.

Data Enclave Contribution Process:

Step 1: Register to become a member of N3C/CD2H to obtain access to meetings invitations, documents, discussion channels, and mailing lists.

  • The N3C Registration Resources page provides links to relevant documents, resources, and communications.
  • See the NCATS N3C webpage to find additional program resources and governance documents.
Register to become a member of N3C/CD2H

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

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 before moving forward.

Other IRB Documents:

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.

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.