General (For all diseases)

Data Standards

Updated CDEs for sexual orientation and gender identity to be developed.

The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. The development of the first set of General Common Data Elements (CDEs) began in 2006. The General CDEs were not developed by a Working Group like the disease specific CDEs. Rather the NINDS CDE Team developed the General CDEs by first identifying those data elements that were common across neurological diseases and then harmonizing these common data elements with other relevant clinical data standards (refer to the Project Overview for more information). The NINDS CDE Steering Committee initially reviewed and continues to oversee all revisions and additions to the General CDEs.

The Core data elements to be used by an investigator when beginning a research study in all NINDS related studies are listed in the Start-up Resource Listing.

Digital technology is an important emerging area in clinical research. In 2022, the NINDS Parkinson’s Disease v2.0 CDE Digital Technology Subgroup developed two guidance documents for this subdomain which may also have utility across disorder areas. Please refer to Best Practices for Digital Health Outcomes and Guidance for Digital Data Sharing for more information.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

Organized by domains and subdomains, often used in clinical studies, data standards include:

There are file links for the CRF module or Notice of Copyright that will allow you to view and/or download the form. The corresponding CDE Details link will direct you to a separate page to download the specific CDEs related to that CRF module or instrument. Please note that not all instruments have CDE details available, due to copyright restrictions.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and subdomain.

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.

Form Search Instructions - Please Read Before Searching

The Form Search is designed to filter the CRF Modules, Guidance Documents, and NOCs on this page by Search Term, Domain, Subdomain, and/or Copyright Status. The Copyright field is designed to filter between forms that are freely available online and forms that are copyrighted or trademarked. Please note that regardless of copyright/trademark status, these instruments are not available on this website. All recommended instruments, regardless of copyright status, have informational documents posted on the NINDS CDE website which provide details concerning availability.

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NIH Resources
NIH Resources
CRF Module/Guidance CDEs
National Institutes of Health (NIH) Toolbox N/A
Quality of Life in Neurological Disorders (Neuro-QOL) N/A
Neuro-QOL Adult Bank - Ability to Participate in SRA CDE Details
Neuro-QOL Adult Bank - Anxiety CDE Details
Neuro-QOL Adult Bank - Cognitive Function CDE Details
Neuro-QOL Adult Bank - Communication CDE Details
Neuro-QOL Adult Bank - Depression CDE Details
Neuro-QOL Adult Bank - Fatigue CDE Details
Neuro-QOL Adult Bank - Lower Extremity Function CDE Details
Neuro-QOL Adult Bank - Positive Affect and Well-Being CDE Details
Neuro-QOL Adult Bank - Satisfaction with SRA CDE Details
Neuro-QOL Adult Bank - Sleep Disturbance CDE Details
Neuro-QOL Adult Bank - Stigma CDE Details
Neuro-QOL Adult Bank - Upper Extremity CDE Details
Patient-Reported Outcomes Measurement Information System (PROMIS) N/A
PROMIS Ability to Participate Item Bank and Short Forms N/A
PROMIS Alcohol Use Item Banks N/A
PROMIS Anger Item Bank N/A
PROMIS Anxiety Item Bank N/A
PROMIS Cognitive Function Item Banks N/A
PROMIS Depression Item Bank N/A
PROMIS Dyspnea Item Banks N/A
PROMIS Scale v1.2 - Global Health N/A
PROMIS Self-Efficacy for Managing Chronic Conditions Item Bank N/A
PROMIS Sleep Item Banks N/A
PROMIS Smoking Item Banks N/A
PROMIS Pain Behavior Item Bank and Short Form N/A
PROMIS Pain Interference Item Bank N/A
PROMIS Pediatric Life Satisfaction Short Forms N/A
PROMIS Pediatric Meaning and Purpose Short Forms N/A
Participant Characteristics
Demographics
CRF Module/Guidance CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guidance CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guidance CDEs
Behavioral History CDE Details
Family History CDE Details
Medical History CDE Details
Assessments and Examinations
Imaging Diagnostics
CRF Module/Guidance CDEs
Diffusion Tensor Imaging (DTI) CDE Details
Magnetic Resonance Imaging (MRI) CDE Details
Non-Imaging Diagnostics
CRF Module/Guidance CDEs
Electrophysiology CDE Details
Electrocardiogram (ECG) CDE Details
Laboratory Tests and Biospecimens/Biomarkers
CRF Module/Guidance CDEs
Laboratory Tests and Tracking CDE Details
NINDS Repository Controls Data Elements N/A
Physical/Neurological Examination
CRF Module/Guidance CDEs
Physical Exam CDE Details
Vital Signs and Other Body Measures
CRF Module/Guidance CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Drugs
CRF Module/Guidance CDEs
Prior and Concomitant Medications CDE Details
Study Drug Compliance CDE Details
Study Drug Dosing CDE Details
Therapies
CRF Module/Guidance CDEs
Study Therapies Compliance CDE Details
Protocol Experience
Participant/Subject Identification, Eligibility, and Enrollment
CRF Module/Guidance CDEs
Inclusion and Exclusion Criteria CDE Details
Informed Consent and Enrollment CDE Details
Screening Log CDE Details
Study Management
CRF Module/Guidance CDEs
Participant/Subject Contact Information CDE Details
Visit Checklist CDE Details
Visit Schedule CDE Details
Protocol Deviations
CRF Module/Guidance CDEs
Protocol Deviations CDE Details
Off Treatment/Off Study
CRF Module/Guidance CDEs
Study Discontinuation/Completion CDE Details
Safety Data
Adverse Events
CRF Module/Guidance CDEs
Adverse Events CDE Details
Serious Adverse Events CDE Details
Outcomes and End Points
Clinical Event End Points
CRF Module/Guidance CDEs
Death Report CDE Details

Prospective Assessments for Suicidal Ideation and Behavior

Investigators should review the FDA’s "Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials” for the most up-to-date information about suicidal ideation and behavior. One scale that FDA suggests is the Columbia Suicide Severity Rating Scale (C-SSRS) (available at https://cssrs.columbia.edu/).

Instrument Notice of Copyright Information

The NINDS CDE Team does not post proprietary instruments/scales recommended by the CDE Working Groups on this website. This includes, but is not limited to, copyrighted or trademarked instruments/scales. Information about recommended instruments can be found in the Notice of Copyright (NOC) documents under ‘CRF Module/Guidance’ on each disorder’s data standards page. For any questions regarding these instruments/scales please contact the corresponding owner/author. The NINDS CDE Team is not responsible for the availability or content of these external sites, nor does the NINDS CDE Team endorse, warrant or guarantee the products, services or information described or offered at these other internet sites.

Overview

The development of General Common Data Elements were the initial focus of the Common Data Element (CDE) Project and were first published (Version 1.0) on this Web site in 2007. The General CDE Standards are designed to be applicable to studies involving a wide range of neurological disease and conditions. Examples of elements included in the General CDEs are: demographic data, medical history data, treatment and intervention data, and safety data. Investigators are encouraged to collect these data elements, if appropriate, in their clinical research studies.

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines available below are organized into domains which are intuitive and common to most clinical research studies. Select a domain of interest below to find the related data standards.

Roster

The General CDEs were not developed by a Working Group like the disease-specific CDEs. Rather the NINDS CDE Team developed the General CDEs by identifying those data elements that were common across neurological diseases and attempting to harmonize with other relevant clinical data standards (refer to the Project Overview for more information). The General CDEs were initially reviewed by the NINDS CDE Steering Committee and that committee continues to oversee all revisions and additions to the General CDEs. The rosters for the CDE Steering Committee and the NINDS CDE Team, including downloadable versions, are shown below.

Complete General CDE Working Group Roster

CDE Steering Committee Members (Voting Members)

CDE Steering Committee Members (Voting Members)

  • Noelle Carlozzi, PhD
    University of Michigan Medical School, Ann Arbor, Michigan
    Co-Chair
  • Vanessa Noonan, PhD, PT
    Praxis Spinal Cord Institute, Vancouver, British Columbia, Canada
    Co-Chair
  • Karen Anderson, MD
    Georgetown University Medical Center, Washington, District of Columbia
  • Ulrich Batzdorf, MD
    University of California, Los Angeles, Los Angeles, California
  • Joline Brandenburg, MD
    Mayo Clinic, Rochester, Minnesota
  • Mitchell Brin, MD
    Abbvie, Inc., Irvine, California
  • Gary Cutter, PhD
    The University of Alabama, Birmingham, Birmingham, Alabama
  • Thomas DeGraba, MD
    The National Intrepid Center of Excellence, Bethesda, Maryland
  • Dennis Dlugos, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Debra J. Ehrlich, MD, MS
    National Institutes of Health (NIH), Bethesda, Maryland
  • Jordan Elm, PhD
    Medical University of South Carolina, Charleston, South Carolina
  • Jacqueline French, MD
    New York University, Comprehensive Epilepsy Center, New York, New York
  • Joseph T. Giacino, PhD
    Spaulding Rehabilitation Hospital, Charlestown, Massachusetts
  • Allen Heinemann, PhD
    Northwestern University, Shirley Ryan AbilityLab, Chicago, Illinois
  • Michio Hirano, MD
    Columbia University Medical Center, New York, New York
  • Virginia Howard, PhD
    University of Alabama, Birmingham, Birmingham, Alabama
  • Susan T. Iannaccone, MD, FAAN
    University of Texas Southwestern Medical Center, Dallas, Texas
  • Edward Kasarskis, MD, PhD
    University of Kentucky College of Medicine, Veterans Affairs Medical Center, Lexington, Kentucky
  • Walter Kukull, PhD
    University of Washington, School of Public Health, Seattle, Washington
  • Irene Litvan, MD, FAAN, FANA
    University of California, San Diego, La Jolla, California
  • Fred Lublin, MD
    Mount Sinai Medical Center, New York, New York
  • David Lynch, MD, PhD
    University of Pennsylvania, Philadelphia, Pennsylvania
  • Jeffrey Saver, MD, FAHA, FAAN
    University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California
  • Todd J. Schwedt, MD
    Mayo Clinic, Phoenix Arizona
  • Julie C. Stout, PhD
    Monash University, Victoria, Australia
  • Kimberly Sullivan, PhD
    Boston University School of Public Health, Boston, Massachusetts
  • Caroline Tanner, MD, PhD
    The Parkinson's Institute, Sunnyvale, California
  • Jarred Younger, PhD
    The University of Alabama, Birmingham, Birmingham, Alabama

NINDS CDE Team

NINDS CDE Team

  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Director, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland (Until 2018)
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC Rockville, Maryland
  • Robin Feldman, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland

Previous CDE Steering Committee Members

Previous CDE Steering Committee Members

  • Tetsuo Ashizawa, MD
    Houston Methodist Research Institute, Houston, Texas
  • Nicholas Barbaro, MD
    University of California, San Francisco, San Francisco, California
  • Lucie Bruijn, PhD
    ALS Association, Washington, District of Columbia
  • Andrew Charles, MD
    UCLA School of Medicine, Los Angeles, California
  • Roderick Corriveau, PhD
    Coriell Institute for Medical Research, Camden, New Jersey
  • Laurie Gutmann, MD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Chelsea Kidwell, MD
    Georgetown University, Washington, District of Columbia
  • Karl Kieburtz, MD, MPH
    University of Rochester, Rochester, New York
  • Roger Kurlan, MD
    University of Rochester, Rochester, New York
  • Melanie Leitner, PhD
    Accelerating NeuroVentures, LLC, Boston, Massachusetts
  • David Loring, PhD
    Emory University, Atlanta, Georgia
  • Andrew Maas, MD, PhD
    University Hospital Antwerp, Edegem, Belgium
  • Richard Moxley, MD
    University of Rochester, School of Medicine and Dentistry, Rochester, New York
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina
  • Ralph Sacco, MD, MS
    University of Miami, Miller School of Medicine, Miami, Florida
  • Ira Shoulson, MD
    Georgetown University, Washington, District of Columbia
  • Zachary Simmons, MD
    Georgetown University, Washington, District of Columbia
  • Barbara Tilley, PhD
    University of Texas School of Public Health, Austin, Texas

CDE Steering Committee Members (Non-Voting Members)

CDE Steering Committee Members (Non-Voting Members)

  • Chuck Cooper, MD
    Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) (2011-2013), Washington, District of Columbia (until 2011)
  • Michael D'Andrea, PhD
    Coriell Institute, Camden, New Jersey (until 2011)
  • Lisa Federer, PhD, MLIS
    National Library of Medicine (NLM), National Institutes of Health (NIH), Bethesda, Maryland
  • Michael Feolo, MS
    National Center for Biotechnology Information, Bethesda, Maryland (Until 2021)
  • Kerry Goetz
    National Eye Institute (NEI), National Institutes of Health (NIH), Bethesda, Maryland
  • Bron Kisler
    Clinical Data Interchange Standards Consortium (CDISC), Austin, Texas (until 2017)
  • Naomi Kleitman, PhD
    Craig H. Neilsen Foundation, Encino, California (Until 2021)
  • Danuta Krotowski, PhD
    National Institutes of Health (NIH), Bethesda, Maryland (Until 2021)
  • Marcia Levenstein, ScD, MBE
    Vivli, Boston, Massachusetts
  • Erica Littlejohn, PhD
    University of Kentucky College of Medicine, Lexington, Kentucky
  • Susan Marden, PhD
    National Institute of Child Health and Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland
  • Matthew McAuliffe, PhD
    Federal Interagency Traumatic Brain Injury Research Project, Bethesda, Maryland
  • Christian A. Perez, PhD
    Coriell Institute for Medical Research, Camden, New Jersey (Until 2021)
  • Erin Ramos, PhD, MPH
    National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland (Until 2021)
  • Yaffa Rubinstein, PhD
    National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Bethesda, Maryland (Until 2021)
  • Lindsey Scott, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sudhir Sivakumaran, PhD
    Critical Path Institute, Tucson, Arizona
  • Chi Tarn, PhD
    Coriell Institute for Medical Research, Camden, New Jersey (until 2015)
  • Lynne Wolfe, MS, CRNP
    National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland

Publications

Publications

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.

General CDEs Revision History