NINDS Preclinical Common Data Elements (CDEs) and Data Standards

The primary objective for developing preclinical common data elements (CDEs) is to produce a well-defined lexicon for describing and reporting how preclinical data are collected with the goal of enhancing rigor, reproducibility and transparency in study performance. The goal of CDEs is to develop a tool to improve standardization of data collection such that experimental details and procedures are reported in a standard transparent manner that allows for rigor and reproducibility. Additionally, it is important for data to be collected, reported and curated in a standardized manner and format that will allow researchers to share data across sites and reuse data for either secondary analyses or big data analyses.

The National Institute of Neurological Disorders and Stroke (NINDS) continues to lead and provide support for the development and refinement of preclinical CDEs and data standards for neurotrauma preclinical research in partnership with the DoD and Veterans Affairs (VA) through the VA-funded interagency resource center PRECISE-TBI and International community partners. 

NINDS has launched the Neurotrauma Preclinical Common Data Elements (CDE) & Data Standards (NT-PRECEDS) Program in January 2025. NT-PRECEDS at NINDS is a parallel and complimentary effort with interagency partners funding Federal Interagency Traumatic Brain Injury Research (FITBIR) and Pre-Clinical Interagency Research Resource-TBI (PRECISE-TBI).

NT-PRECEDS Program

The Neurotrauma Preclinical Common Data Elements (CDE) & Data Standards (NT-PRECEDS) Program at NINDS is a parallel and complimentary effort with interagency partners funding Federal Interagency Traumatic Brain Injury Research (FITBIR) and Pre-Clinical Interagency Research Resource-TBI (PRECISE-TBI).  

Goals of NT-PRECEDS program: The primary focus and overall goal is to provide support for the development, curation, and harmonization of preclinical CDEs for three Neurotrauma projects: Traumatic Brain injury, Post-Traumatic Epilepsy (PTE) and Spinal Cord Injury (SCI). This effort is led by Dr. Hibah O. Awwad who oversees the management, coordination and progress of the program.

The goals of the NT-PRECEDS program at NINDS will be achieved via 4 objectives:

1. Developing, curating and harmonizing preclinical CDEs for 3 Neurotrauma projects:  Traumatic Brain Injury (TBI), Post Traumatic Epilepsy (PTE) and Spinal Cord Injury (SCI) projects. 

2. Developing a set of “core” preclinical CDEs and metadata CDEs harmonized across all 3 neurotrauma preclinical projects, to become the NIH-endorsed preclinical CDEs that will be cataloged in the NLM NIH-endorsed CDE repository.

3. Developing semi-automated tools that will facilitate the use of preclinical CDEs by researchers for data collection, data analysis, data reporting and data sharing. The program will initially address one of the challenges by supporting data scientists to develop a tool to transform raw datasets and map them to Data elements (DE). This will include the ability to browse, identify and select DEs & CDEs before starting their project. This will address the initial barrier of utilization of CDEs by making this API interface user-friendly and making CDEs findable and interoperable; especially for preclinical researchers that are new to data science and data sharing. 

4. Dissemination of progress and updates on preclinical CDEs & data standards to preclinical investigators: Discussions/Conversations with preclinical research scientists related to topics that include current data standards, rigor & reproducibility (ARRIVE guidelines), data harmonization, using CDEs to collect data, analyze data and publish data, share data in various repositories, relevance to clinical CDEs. This will occur through a variety of methods including, but not limited to webinar series, presentations at national meetings, tutorial documents & recorded videos shared to an NINDS-public facing website.

Acknowledgement: The NT-PRECEDS program is supported by funds from the Vivian L. Smith Foundation. Contractor support is provided by Publicis Sapient Contract Team. 

NINDS Preclinical CDE Repository

The NINDS Preclinical CDE Repository hosts the preclinical CDEs that are currently being developed by the NeuroTrauma PREclinical CDE & Data Standard (NT-PRECEDS) program at NINDS

NT-PRECEDS Steering Committee

The NT-PRECEDS Steering committee you will play a key role, including but not limited to, helping to identify critical issues, shaping and harmonizing the preclinical CDE data standards in neurotrauma research within the various contexts of use of scientific research data. 

The steering committee consists of the CDE leads for each project, NINDS and NIH staff and federal partners listed below:

NT-PRECEDS Working groups

Executive Committees:

• TBI Executive Committee
• PTE Executive Committee
• SCI Executive Committee

TBI Executive Committee Members:

PTE Executive Committee Members:

SCI Executive Committee Members:

Working groups:  

• Neurotrauma Working Group
• Data Science Working Group

Neurotrauma Working group members:  

Data Science Working group members: 

SubWorking groups (alphabetical order):

1. Behavioral Outcomes (TBI/PTE)
2. EEG and Seizures​ (TBI/PTE)
3. Functional Outcomes (SCI)
4. Genomics​ (TBI/PTE/SCI)
5. Histopathology​ (TBI/PTE/SCI)
6. Imaging​  (TBI/PTE)
7. Injury Models (TBI/PTE)
8. Injury Models (SCI)
9. Lipidomics (TBI/PTE/SCI)
10. Metabolomics (TBI/PTE/SCI)
11. Pharmacology and Interventions​ (TBI/PTE/SCI)
12. Proteomics Biomarkers​ (TBI/PTE/SCI)
13. Review Existing CDEs (SCI)
14. Rigor and Experimental Design (SCI)

Behavioral Outcomes (TBI/PTE) subworking group members: 

EEG and Seizures (TBI/PTE) subworking group members: 

Functional Outcomes (SCI) subworking group members: 

Genomics (TBI/PTE/SCI) subworking group members: 

Histopathology (TBI/PTE/SCI) subworking group members: 

Imaging (TBI/PTE) subworking group members: 

Injury Models (TBI/PTE) subworking group members: 

Injury Models (SCI) subworking group members: 

Lipidomics (TBI/PTE/SCI) subworking group members: 

Metabolomics (TBI/PTE/SCI) subworking group members: 

Pharmacology & Interventions (TBI/PTE/SCI) subworking group members: 

Proteomics Biomarkers (TBI/PTE/SCI) subworking group members: 

Review Existing CDEs (SCI) subworking group members: 

Rigor & Experimental Design/Bias (SCI) subworking group members: 

Publicist Sapient CDE Team members

Events/Resources/Links

• 2025 NINDS/NIH-Sponsored Preclinical CDE workshop at NNS - Watch here
• NINDS Preclinical CDEs/Data Standards:
  • January 28, 2026:  Where things started and where are we now? Event page | Watch here
  • February 25, 2026: The NIH Perspective on Common Data Elements Event page | Watch here
  • March 18, 2026: The Missing Link: How CDEs Bridge Best Practices, Neurotrauma Data Repositories and AI Event page | Watch here
  • April 15, 2026: How may CDEs Enhance Rigor and Translation? Event page | Watch here
  • May 18, 2026: PRECISE-TBI: Tools to Improve Rigor and Reproducibility of Preclinical TBI Research Event Page| Recording coming soon
  • June 10, 2026: Preclinical Common Data Elements in Stroke Research - The SPAN Experience Register here
• IdeaScale Crowdsourcing Public Campaign
• IdeaScale Working groups only (special access needed)

Updates/History of NINDS Preclinical CDE projects

• TBI preclinical CDE history
• Archived Overview of 2016-2019 Traumatic Brain Injury Preclinical Working group
  • As such, the working groups (WGs) were asked to determine the level of experimental detail that should be reported in order to improve inter-investigator data harmonization.
  • The TBI Preclinical Working Groups intended to address the challenge that, while well-validated and standardized animal models of TBI can enhance our understanding of disease and inform therapeutic development, many therapeutics that show promise in preclinical models fail to elicit predicted effects when tested clinically. These meetings explored the relationship between clinical phenotypes of TBI and animal model constructs, and discussed what constitutes a useful translation model system and common data elements for data standardization, particularly in the context of Research and Development decision making.
  • To develop the Preclinical Traumatic Brain Injury (Preclinical TBI) CDEs, the Preclinical TBI CDE Working Group divided into three sub-working groups to focus on identifying and defining data elements in the domains of:
  • SWG1 - General Health Affective Disturbance (Depression/Anxiety/Social Interaction)
  • SWG2 - Cognition and Motor (Learning/Memory/Sensory/Motor)
  • SWG3 - Large Animal Models (Behavior)
• Archived Data Standards
  • The Preclinical TBI CDE Working Group, the National Institute of Neurological Disorders and Stroke (NINDS) and the Department of Defense (DOD) CDE Team have released a draft version (Pre-release Version 0.1) of the Preclinical TBI CDE recommendations for Public Review.
  • Please Note: These recommendations are still in the process of being reviewed, updated, and edited by the Working Group during the public review period. Additional instruments and data will be posted with the final recommendations release in April 2018. We also understand that Preclinical TBI is a relatively new area of data harmonization, specially for large animal models and further clinical investigation is needed.
  • After the public review period, the Preclinical TBI CDE Working Group will review and revise the recommendations as needed. Version 1.0 of the Preclinical TBI CDE recommendations will be posted by April 2018. Again, please note that changes are still being incorporated and final documents for community use will not be available until April 2018.
• Archived PRECLINICAL TBI COMMON DATA ELEMENT PUBLIC REVIEW PACKAGE OVERVIEW

  • The Pre-release Version 0.1 Preclinical TBI Public Review package consists of one zip file (PreclinicalCDE2_v0.1_113017.zip) containing the following documents:

    1. Instructions

    • Instructions(pdf, 116 KB) on reviewing CDE's and submitting comments

    2. CDE Spreadsheet Guide

    • Description for  the CDE spreadsheet columns; please review columns A, B, C, E, F, G, H, I, J, K, L, M, O, P, Q, R

    3. Quick Start Guide

    • Provides a reference for each of the tests/outcomes for the preclinical TBI common data elements (CDEs)

    4. Common Data Elements (CDE) sets for each test/instrument

    • CDE sets are available as excel spreadsheets, which include the CDEs identified and defined by the Preclinical TBI Working Groups. The CDE sets can be used as the building blocks for study data collection forms

    5. Comments form spreadsheet

    • Reviewers should use this spreadsheet to return comments to the working group (PreclinicalCDE@nih.gov)

    It is anticipated that many of the CDEs will overlap across outcome measures and study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is maintained in order to ensure the ability to transfer critical medical information electronically from one center to another. This data harmonization also allows for continuity across different disease areas. The goals of the NINDS/DOD CDE initiative are to increase the efficiency and effectiveness of preclinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate investigators who are new to TBI research.

• Archived CDE Classification 
  • Each CDE or instrument will be classified according to the definitions below once public review has been completed in April, 2018:
  • General Core: A data element that is vital to the reporting of all preclinical studies, regardless of disease category.
  • Disease Core: A data element that collects essential information applicable to any disease-specific study, including all therapeutic areas. The preclinical working groups assign the disease “Core” classification based on a consensus of best research practices from the literature. The disease Core CDEs are a small subset of the available CDEs, and it is anticipated that investigators will need to collect the disease Core CDEs on any type of study since they are vital to the reporting of all disease-specific studies.
  • Disease Supplemental - Highly Recommended: A data element which is essential based on certain conditions or experimental designs to test the outcome in a particular domain.  In most cases, these are well-established experimental factors that are known to influence the measured outcome. These data elements are highly recommended for the specified disease condition, study type or design.
  • Disease Supplemental: A data element which is commonly collected in pre-clinical research studies. Use depends upon the study design, protocol or type of research involved. These are recommended, but not vital, for studies.
  • Disease Exploratory: A data element that requires further validation, but may fill current gaps in the CDEs and/or substitute for an existing CDE once validation is complete. Such data elements show great promise, but require further validation before they are ready for prime-time use. They are reasonable to use with the understanding of their limited validation.
• Archived History and Acknowledgements
  • Chairs and co-chairs were appointed to lead and the three individual pre-clinical TBI sub-working groups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The Preclinical TBI CDE Working Groups were supported by the NINDS/DOD CDE Team.
  • The rosters for the Preclinical TBI CDE subgroups are shown below:
  • SWG1 - General Health /Affective Disturbance (Depression/Anxiety/Social Interaction)

  • NAME	AFFILIATION
    Adam Bachstetter, PhD	University of Kentucky
    Chantelle Ferland-Beckham, PhD	Cohen Veterans Bioscience
    Candace Floyd, PhD [Co-Chair]	University of Alabama at Birmingham
    Aristea Galanopoulou, MD, PhD	Albert Einstein College of Medicine
    Patricia Kabitzke, PhD	Cohen Veterans Bioscience
    Michelle LaPlaca, PhD [Chair]	Biomedical Engineering Georgia Tech
    Vance Lemmon, PhD	University of Miami Miller School of Medicine
    Jonathan Lifshitz, PhD	University of Arizona
    Helen Scharfman, PhD	Nathan S. Kline Institute for Psychiatric Research
    Doug Smith, MD	University of Pennsylvania

  • SWG2 - Cognition and Motor (Learning/Memory/Sensory/Motor)

  • NAME	AFFILIATION
    Adam Bachstetter, PhD	University of Kentucky
    Hulya Bayir, MD	University of Pittsburg Medical Center
    Ed Dixon, PhD [Chair]	University of Pittsburg Medical Center
    Adam Ferguson, PhD	University of California San Francisco
    Stuart Friess, MD	Washington University in St.Louis
    Aristea Galanopoulou, MD, PhD	Albert Einstein College of Medicine
    Ed Hall, PhD [Co-Chair]	University of Kentucky
    Neil Harris, PhD	University of California Los Angeles
    Ramona Hicks, PhD	One Mind for Research
    Patricia Kabitzke, PhD	Cohen Veterans Bioscience
    Michelle LaPlaca, PhD	Biomedical Engineering Georgia Tech
    Jonathan Lifshitz, PhD	University of Arizona
    David Loane, PhD	University of Maryland Medical Center
    Linda Noble, PhD	University of California San Francisco
    Helen Scharfman, PhD	Nathan S. Kline Institute for Psychiatric Research

  • SWG3 – Large Animal Models (Behavior)

  • NAME	AFFLILIATION
    Hasan Alam, MD [Chair]	University of Michigan
    Candace Floyd, PhD	University of Alabama at Birmingham
    Ed Hall, PhD	University of Kentucky
    Ramona Hicks, PhD	One Mind
    Lindsey Hulbert, PhD [Co-Chair]	Kansas State University
    Victoria Johnson, MBChB, PhD	University of Pennsylvania
    Susan Margulies, PhD	University of Pennsylvania
    Vahagn Nikolian, MD	University of Michigan
    Laila Zai, PhD	Applied Research Associates, Inc.

  • NINDS/DOD/FITBIR

  • NAME	AFFILIATION
    Pat Bellgowan, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
    Alicia Tammy Crowder, PhD	Department of Defense (DOD)
    Nsini Umoh, PhD	Department of Defense (DOD)
    Diana Cummings, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
    Carol Taylor-Burds, PhD	National Institute of Neurological Disorders and Stroke (NINDS)
    Matt McAuliffe,PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)
    Olga Vovk, PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)
    Leonie Misquitta, PhD	Federal Interagency Traumatic Brain Injury Research (FITBIR)

     

  • Note: Institutions for all individuals acknowledged in this section were those they belonged to when they joined the Committee.
• Archived Previous Preclinical Public Review Documents
  • Public Review Round 1 Period: June 12th – August 21st, 2017, Preclinical TBI CDE PUBLIC REVIEW 1 ZIP FILE
  • Public Review Period Round 2: 12/01/17-02/28/18 (December 2017-February 2018)
  • Preclinical TBI CDE Round 2 PUBLIC REVIEW ZIP FILE

• Archived Contact 

  Please contact PreclinicalCDE@nih.gov if you require further information or have any questions about the Common Data elements.

Contact Us

• NINDS Preclinical CDE team:
  • Dr. Hibah O. Awwad
  • Dr. Severn (Ben) Churn
  • Dr. Claudio Villalobos-Dintrans
  • Dr. Gabriel (Gabe) Gonzales
• Publicis Sapient Team:
  • Ms. Sherita Ala'i
  • Dr. Henry Ogoe

For NINDS Clinical CDEs, please visit the NINDS CDE Repository