The Data Transfer Agreement (DTA) is a legal document that covers the terms of the transfer of data to N3C Clinical. 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.
IRB approval is required to transfer a limited dataset to the N3C Clinical 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 Clinical protocol. If you choose to undergo review with your local IRB, a copy of your site’s approval letter must be submitted before moving forward.
This initial IRB approval is intended to cover only the contribution of data to N3C Clinical and does not cover research using N3C Clinical 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 Clinical IRB requirements, please contact Tricia Francis before moving forward.
Other IRB Documents:
NOTE: Execution of the DTA and IRB approval are both required before submitting data to the N3C Clinical Data Enclave. Once they are in place, N3C Clinical will offer a “white glove” service to assist with the data exchange process.