About NACC's Uniform Data Set#

Working in collaboration with the Alzheimer’s Disease Research Centers (ADRC) Program, currently comprised of 35 centers across the United States, NACC has built an extensive 50,000+ participant longitudinal database of standardized clinical and neuropathological research data that is freely available to all researchers. The NACC Uniform Data Set (UDS) includes rich multi-domain neurocognitive clinical and phenotypic data and robust criteria-based diagnoses. Centers enroll participants who are healthy, at risk, and with dementia symptoms and then research experts collect standardized longitudinal data through annual visits using research tools co-developed and provided by NACC.

52,500+ participants with data at NACC

19,000+ active participants

195,000+ clinical assessments

1 - 17 per participant (median = 3)

8,150+ neuropathology exams

from 58% of deceased participants

1,350+ published studies

using NACC data

35 ADRCs and 1 Exploratory Center

currently contributing data across 24 states

Expanding participant diversity

Introducing Version 4 of the Uniform Data Set (UDSv4)#

The UDS was introduced in 2005 to standardize longitudinal neurocognitive data collection across NIA’s Alzheimer's Disease Research Centers (ADRC) Program currently comprised of 35 centers. NACC convenes a Clinical Task Force, comprised of leading dementia experts from across the US, every few years to develop a new version of the UDS that is aligned with important scientific advances in Alzheimer's Disease and Related Dementia (ADRD) research, detection, and care.

The last update to the UDS (v3) was released in 2015. Since then, the AD/ADRD field has made significant progress making it critical to update the UDS once again. UDSv4 introduces a form focused on social determinants of health (SDOH) as well as updated, more inclusive questions on gender identity, sexual orientation, and multi-racial and -ethnic identities which will enable researchers to explore new and critical questions related to diversity, equity, and inclusion (DEI) research. NACC and the CTF strive to foster inclusion with these questions as well as promoting best practices for engaging indigenous communities across the ADRCs, providing Spanish and Chinese translations of the UDS, and implementing electronic data capture (EDC) to improve accessibility for UDS participants.

UDSv4 will also advance the AD/ADRD field with a new form focused on AD/ADRD-disease modifying drugs as well as new concepts throughout the UDS including subjective cognitive decline, mild behavioral impairment, and a verbal learning test to assess new cognitive domains.

UDSv4 Tools & Resources for ADRCs#

Supporting ADRCs through the transition to UDSv4#

To aid ADRCs with the transition to UDSv4 and the new data submission options, please use the following resources:

General#

• Preview UDSv4 Onboarding Checklist - (coming soon) Preliminary step-by-step instructions with links to every resource ADRCs need to get started. We welcome your feedback on the checklist.

• Moderated ADRC Program Community Forum (powered by Discourse) - (coming soon) A private, invitation-only moderated forum for ADRC members to view FAQs, ask questions, get answers, and collaborate with ADRC, NIA, CTF, EDC Workgroup, and NACC colleagues across the ADRC Program. A one-stop shop for self-serve, asynchronous support and collaboration that is accessible 24/7.

• Office Hours (coming soon) - Unstructured Zoom meeting times where ADRC members can join and ask questions of NACC's Technology, REDCap, and Research Teams

• UDSv4 FAQ – A continuously updated list of the most common questions and answers will be available on Discourse and through a link on the NACC Website

Clinical#

• Preview UDSv4 Forms and Coding Guidebook - Familiarize yourself with the preliminary guidance on how to administer the UDSv4 forms

• Live Trainings / Webinars - NACC in collaboration with the CTF and EDC Workgroups will offer both live and recorded clinical and data manager training webinars

  	February 2024 UDSv4 Cognitive Task Force Webinar Presenter Dr. Kostas Lyketsos uses a case-based approach to ratings of neuropsychiatric symptoms and mild behavioral impairment on Form D1a and related forms.
  	Operationalizing “Impaired, not MCI” in UDSv4 This webinar addresses operationalizing “Impaired, not MCI” vs MCI in the UDSv4 including an overview of the item on UDSv4 Form D1a.
  UDSv4 Virtual Clinical Training Workshop Our experts present an overview of the new modules, features, forms, and changes in the UDSv4. For more info, view our Q&A for answers regarding the UDSv4 forms and data collection. Forms A1 & A2 Presented by Clinical Task Force Member Dr. Greg Jicha of University of Kentucky ADRC. Form A1a Presented by Clinical Task Force Members Dr. Lisa Barnes of Rush University ADRC and Dr. Megan Zuelsdorff of UW Madison ADRC. Form A4 Presented by Clinical Task Force Member Dr. Teresa Gomez-Isla of Massachusetts ADRC. Form A4a Presented by Clinical Task Force Member Dr. Suzanne Schindler of Washington University ADRC. Form A5/D2 Presented by Clinical Task Force Member Dr. Aimee Pierce of OHSU ADRC. Form B3 Presented by Clinical Task Force Member Dr. Brad Boeve of Mayo Clinic ADRC. Form B8 Presented by Clinical Task Force Member Dr. Brad Boeve of Mayo Clinic ADRC. Form B9 Presented by Clinical Task Force Member Dr. Kostas Lyketsos of Johns Hopkins ADRC. Form C2/C2T Presented by Clinical Task Force Members Dr. Lisa Barnes of Rush University ADRC and Dr. Andy Saykin of Indiana ADRC. Form D1a Presented by Clinical Task Force Members Dr. Jeff Burns of Kansas University ADRC, Dr. Andy Saykin of Indiana ADRC, and Dr. Kostas Lyketsos of Johns Hopkins ADRC. Form D1b Presented by Clinical Task Force Member Dr. Jeff Burns of Kansas University ADRC.

Technical#

General Technical Resources

• Moderated ADRC Program Community Forum (powered by Discourse) (coming soon) - Find technical assistance, interact with experts, and collaborate with others across the ADRC program.

• Preview the REDCap forms - Start preparations for the new UDSv4 data by familiarizing yourself with the preliminary forms.

• Technical Documentation & REDCap SOPs - Instructions and best practices, including: calculated fields, custom reporting, data access groups, REDCap data quality rules, data dictionaries, customization of user roles, how to use Crosswalks, JSON files, XML, and more.

• File Downloads Download UDSv4 files including REDCap Project XML, Data Dictionary, Coding Guidebook, and individual form resources including REDCap Instrument Zip files, PDFs, Crosswalks, and JSON versions of the crosswalks.

• NACC GitHub Library Access and download software, code for error checks, and other technical resources.

• UDSv3 to UDSv4 Crosswalks - Data harmonization instructions between UDSv3 and UDSv4 for each form.

• NACC Data Platform Sandbox (coming soon) – Practice environment for ADRCs to test data submissions and API submissions without impacting finalized or “real” data

UDSv4 Digital Voice Resources

• UDSv4 Digital Voice Webpage - Provides a central hub for ADRCs interested in learning more about digital voice data collection as part of UDSv4. NACC and the CTF Technology WG have collaborated on several resources hosted on this webpage to aid ADRCs in collecting digital voice data. At this time, digital voice capture is encouraged but not required. Resources available on the UDSv4 Digital Voice webpage include:

• Digital Voice Start-up Checklist - A guide for ADRC's and other interested groups in getting started to collect digital voice audio recordings as part of the UDSv4 cognitive exam for research analysis.

• IRB Protocol and Informed Consent Language - Provides ADRC's with guidelines, example IRB protocol and informed consent language, and helpful suggestions to aid centers in obtaining regulatory compliance for the collection and storage of digital voice data as part of UDSv4.

• Preview of Digital Voice Recording Manual - Provides in-depth instructions and best practices for collecting, storing, and processing digital voice data at your ADRC.

UDSv4 Data Collection and Submission Options and Resources

UDSv4 data collection options

ADRC Local REDCap	Use NACC’s UDSv4 REDCap project XML file or Data Dictionary Use this XML file to instantly create a UDSv4 project on your local REDCap instance to collect UDSv4. Alternatively, you can use the Data Dictionary to import individual UDSv4 instruments into an existing project on your local REDCap instance.
Alternative ADRC Local EDC System	Collect data using your own local EDC (coming soon) ADRCs may use their own local EDC for data collection. NACC has published a REDCap Data Dictionary, Coding Guidebooks, Data Crosswalks and a Data Element Dictionary for building or modifying an EDC to collect UDSv4 data.
PDF Forms	Collect data using UDSv4 PDFs PDF forms will continue to be available for ADRCs to download and print for initial UDSv4 data collection. In addition to English, NACC will also be making UDSv4 forms available in Spanish, Mandarin, and Cantonese translations.
Direct Entry into NACC REDCap	Enter UDSv4 forms data directly into the NACC hosted REDCap instance Each ADRC will have access to a NACC-hosted UDSv4 REDCAP project available through their ADRC Portal. For further assistance, watch a demo video.

UDSv4 Submission Options via the NACC ADRC Portal

Upload with our API	Programmatic Upload Using an API, upload to the NACC Data Platform using the Flywheel CLI tool or a Flywheel provided SDK.
Bulk CSV Upload	CSV Batch file submission Submit a CSV containing UDSv4 form data to NACC through the ADRC portal.
Automated Submission	Direct Entry Use NACC’s hosted REDCap instance to enter UDSv4 data directly into REDCap forms and submit to the NACC Data Platform.

Additional UDSv4 Data Collection and Submission Training and Resources

Preview UDSv4 Forms#

Updates#

Email Updates#

UDSv4 Timelines#

Collaborations#

Co-Creating the new UDS: NACC Partners with the Clinical Task Force (CTF)#

The Electronic Data Capture Workgroup - A Collaboration with the ADRC Program#

Modernization#

NACC Modernization in Support of UDSv4#

Developing a Modern Electronic Data Capture System Powered by REDCap#