NCATS and Mike Kurilla are asking CTSA members to consider having their institution extend access to the N3C COVID data.
The 3 original agreements - Data Transfer Agreement (DTA), Data Use Agreement (DUA), and the Linkage Honest Broker Agreement (LHBA) - were limited for a period of 5 years. These agreements will begin expiring in 2025. NCATS seeks to extend data access with a new expiration date of September 30, 2029.
This request is to extend the three agreements via amendments by changing the expiration date and the description of data to make recurring updates optional. There are no other changes to their terms. Signing the extension amendments requires no new resources from institutions; it is strictly granting NCATS permission to continue investigators’ access to the existing data. By obtaining permissions, NCATS aims to facilitate uninterrupted research progress while maintaining N3C operations and oversight.
It is, therefore, necessary for institutions to sign an extension to allow continued access to the data.
- COVID Data Transfer Agreement Extension (DTA) Amendment - All institutions that wish to continue providing COVID-19 data to N3C for the purposes of research must sign the COVID Data Transfer Agreement Extension (DTA) Amendment.
- COVID Data Use Agreement Extension (DUA) Amendment - All individuals that wish to continue conducting COVID-19 research using N3C must have their parent organization sign the COVID Data Use Agreement Extension (DUA) Amendment.
- COVID Data Linkage Honest Broker Agreement (LHBA) Extension Amendment - All institutions that wish to continue to allow deduplication and linkages to COVID-19 data to N3C for the purposes of research must sign the COVID Data Linkage Honest Broker Agreement (LHBA) Extension Amendment.
Extending your agreement(s) allows the research community to continue answering COVID questions. With the updated DUA, DTA, and LIHBA access will be extended through September 30, 2029.
The forms to sign are located at these 3 URLs for you to download:
COVID Data Transfer Agreement Extension (DTA) Amendment - COVID Data Use Agreement Extension (DUA) Amendment - COVID Data Linkage Honest Broker Agreement (LHBA) Extension Amendment
Then attach as PDF and email to Chris Dillon at ncatspartnerships@mail.nih.gov, NCATS Office of Strategic Alliances.
All other questions can be sent to NCATS_N3C@nih.gov.
Important Dates for Institutions
- 12/31/2024 - The extension DTA must be signed by 12/31/2024.
- 1/1/2025 - Beginning Jan. 1, 2025, N3C COVID will only release new data from sites that have signed the extension DTA. Sites that wish to continue to allow access to their data beyond 4/1/2025 must sign the new DTA.
- 4/1/2025 - All access to data from a site that does not sign a renewed DTA, including access to previous versions of data, will be revoked on 4/1/2025.
Important Dates for Researchers
- 12/31/2024 - Researchers wishing to maintain access to any N3C COVID data after Dec. 31, 2024, must have their institution sign the extension DUA.
- 1/1/2025 - New data releases will only include patients from sites that have signed the DTA extension, the data included from those sites will remain the same, including patient records from 1/1/2018 and beyond.
- 4/1/2025 - To respect expiring agreements for sites that do not renew their DTA, access to all data from these sites and all derived datasets will be revoked for all users by 4/1/2025. Any datasets or results derived from data releases prior to 12/31/2024 will be archived and must be recomputed using a newer data release.
Additional information is available at https://ncats.nih.gov/research/research-activities/n3c/covid-enclave/resources. If you have any questions, please don't hesitate to reach out to Mike Kurilla (Michael.Kurilla@nih.gov) or Ken Gersing (Kenneth.Gersing@nih.gov).
FAQs
Q: Are there any new or changing requirements between the original Data Transfer and Data Use agreements and the new extensions?
A: No, there are no new requirements. The agreements remain the same, other than changes to the dates and the description of data to make recurring updates optional.
Q: What does signing the new agreements commit the institution to do?
A: The new agreement extensions require no new resources. They grant permission for investigators to continue to access available data
Q: Are institutions required to continue to send data?
A: No. Data Contributors do not have to continue data transfers; however, the extension allows investigators to continue to use data already transferred. N3C will continue to make available the latest data from a site until it is updated by the site.
Q: Will you accept new data from sites in 2025?
A: Yes, N3C will continue to accept new data from sites that have signed DTA extensions with a suggested pace of quarterly updates.
Q: What happens if I do not sign the Data Transfer or Data Use extensions?
A: If your institution, does not sign the Data Transfer Agreement Extension, existing research studies will lose access to your data in early 2025.
A: If your institution does not sign the Data Use Agreement Extension, your investigators will lose access to the N3C COVID data.
Q: If I put in a DUR now how long will I have access to the 84 sites presently in N3C?
A: Because the DTA was limited to 5 years, access to that data will end 3/31/2025. While your workspace will continue to exist, it will eventually only have access to data inputs from institutions that have signed the extension DTA.
Q: What happens to all my prior work?
A: Assuming that you are covered by an updated DUA, any prior work will be unaffected. However, any results will need to be generated from data released after 12/31/2024. Starting 4/1/2025, any datasets or results derived from data releases prior to 12/31/2024 will be archived and must be recomputed using a newer data release.
Q: Will I lose access to data from the early waves of the pandemic?
A: No, the new agreements authorize access to the exact same data as before from each site. Data dating back to 2018 will be available, just not necessarily from as many sites.
Q: What if I need access to old data releases after 4/1/2025?
A: We recognize that there may be valid scientific reasons to view archival data, e.g. revision or reproductions requested due to ongoing peer review. While we strongly encourage researchers to avoid dependence on older data, specific requests for access to archived data will be considered on an individual basis. Simply needing a larger sample size or more sites worth of data is not an acceptable reason for a request.
