General (For all diseases)

Data Standards

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.

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 sub-domains, often used in clinical studies, data standards include:

There are file links for the CRF module or Notice of Copyright that will direct you to where to find the form. The CDE Details link will take you to a page to download the specific CDEs related to the CRF module or instrument. Due to copyright restrictions not all instruments have CDEs made for them on our website. For your reference, a zip file containing all the current General CDE template CRF modules can be downloaded below.

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

NIH Resources
NIH Resources
CRF Module/Guideline 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 Item Bank v1.0 - Alcohol: Negative Consquences CDE Details
PROMIS Item Bank v1.0 - Alcohol: Negative Expectancies CDE Details
PROMIS Item Bank v1.0 - Alcohol - Positive Consequences CDE Details
PROMIS Item Bank v1.0 - Alcohol - Positive Expectancies CDE Details
PROMIS Item Bank v1.0 - Alcohol Use CDE Details
PROMIS Item Bank v1.1 - Anger CDE Details
PROMIS Item Bank v1.0 - Applied Cognition - Abilities CDE Details
PROMIS Item Bank v1.0 - Applied Cognition - General Concerns CDE Details
PROMIS Item Bank v2.0 - Cognitive Function CDE Details
PROMIS Item Bank v1.0 - Dyspnea Functional Limitations CDE Details
PROMIS Item Bank v1.0 - Dyspnea Severity CDE Details
PROMIS Item Bank v1.0 - Emotional Distress - Anxiety CDE Details
PROMIS Item Bank v1.0 - Emotional Distress - Anxiety CDE Details
PROMIS Item Bank v1.0 - Emotional Distress - Depression (Calibrated Items) CDE Details
PROMIS Item Bank v1.0 - Emotional Distress - Depression CDE Details
PROMIS Item Bank v1.2 - Global Health CDE Details
PROMIS Item Bank v1.1 - Pain Behavior CDE Details
PROMIS Item Bank v1.1 - Pain Interference CDE Details
PROMIS - Scoring CDE Details
PROMIS Item Bank v1.0 - Self-Efficacy for Managing Emotions CDE Details
PROMIS Item Bank v1.0 - Sleep Disturbance CDE Details
PROMIS Item Bank v1.0 - Sleep Related Impairment CDE Details
PROMIS Item Bank v1.0 - Sleep Related Impairment CDE Details
PROMIS Item Bank v1.0 - Smoking: Coping Expectancies for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Coping Expectancies for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Coping Expectancies for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Emotional and Sensory Expectancies for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Emotional and Sensory Expectancies for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Emotional and Sensory Expectancies for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Health Expectancies for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Health Expectancies for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Health Expectancies for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Psychosocial Expectancies for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Psychosocial Expectancies for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Negative Psychosocial Expectancies for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Nicotine Dependence for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Nicotine Dependence for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Nicotine Dependence for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Social Motivations for All Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Social Motivations for Daily Smokers CDE Details
PROMIS Item Bank v1.0 - Smoking: Social Motivations for Nondaily Smokers CDE Details
PROMIS Item Bank v1.0 - Social Activity CDE Details
PROMIS Pediatric Item Bank v1.0 - Life Satisfaction-Short Form 4a CDE Details
PROMIS Pediatric Item Bank v1.0 - Life Satisfaction- Short Form 8a CDE Details
PROMIS Pediatric Item Bank v1.0 - Meaning and Purpose-Short Form 4a CDE Details
PROMIS Pediatric Item Bank v1.0 - Meaning and Purpose- Short Form 8a CDE Details
PROMIS Pediatric Item Bank v1.0 - Pain Behavior-Short Form 8a CDE Details
Participant Characteristics
Demographics
CRF Module/Guideline CDEs
General Core CDE Details
Demographics CDE Details
Social Status
CRF Module/Guideline CDEs
Social Status CDE Details
Participant History and Family History
General Health History
CRF Module/Guideline CDEs
Behavioral History CDE Details
Family History CDE Details
Medical History CDE Details
Assessments and Examinations
Non-Imaging Diagnostics
CRF Module/Guideline CDEs
Electrophysiology CDE Details
Electrocardiogram (ECG) CDE Details
Physical/Neurological Examination
CRF Module/Guideline CDEs
Physical Exam CDE Details
Vital Signs and Other Body Measures
CRF Module/Guideline CDEs
Vital Signs CDE Details
Treatment/Intervention Data
Protocol Experience
Participant/Subject Identification, Eligibility, and Enrollment
CRF Module/Guideline CDEs
Inclusion and Exclusion Criteria CDE Details
Informed Consent and Enrollment CDE Details
Screening Log CDE Details
Protocol Deviations
CRF Module/Guideline CDEs
Protocol Deviations CDE Details
Off Treatment/Off Study
CRF Module/Guideline CDEs
Study Discontinuation/Completion CDE Details
Safety Data
Adverse Events
CRF Module/Guideline CDEs
Adverse Events CDE Details
Serious Adverse Events CDE Details
Outcomes and End Points
Clinical Event End Points
CRF Module/Guideline CDEs
Death Report CDE Details

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.

History and Acknowledgements

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 2011-Present (Voting Members)

  • Lucie Bruijn, PhD
    ALS Association, Washington, District of Colombia
    Chair
  • Nicholas Barbaro, MD
    University of California, San Francisco, San Francisco, California
  • Mitchell Brin, MD
    Indiana University Health Neuroscience Center, Indianapolis, Indiana
  • Andrew Charles, MD
    UCLA School of Medicine, Los Angeles, California
  • Gary Cutter, PhD
    University of Alabama, Birmingham, Birmingham, Alabama
  • Thomas DeGraba, MD
    The National Intrepid Center of Excellence, 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
  • Laurie Gutmann, MD
    University of Iowa Carver College of Medicine, Iowa City, Iowa
  • Virginia Howard, PhD
    University of Alabama, Birmingham, Birmingham, Alabama
  • Karl Kieburtz, MD, MPH
    University of Rochester Medical Center, Rochester, New York
  • Walter Kukull, PhD
    University of Washington, School of Public Health, Seattle, Washington
  • David Loring, PhD
    Emory University, Atlanta, Georgia
  • Fred Lublin, MD
    Mount Sinai Medical Center, New York, New York
  • David Lynch, MD, PhD
    University of Pennsylvania, Philadelphia, Pennsylvania
  • 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
    University of Miami, Miller School of Medicine, Miami, Florida
  • Jeffrey Saver, MD, FAHA, FAAN
    University of California, Los Angeles, Geffen School of Medicine, Los Angeles, California
  • Ira Shoulson, MD
    Georgetown University, Washington, District of Colombia
  • Zachary Simmons, MD
    Georgetown University, Washington, District of Colombia
  • Julie Stout, PhD
    Penn State, Hershey Medical Center, Hershey, Pennsylvania
  • Caroline Tanner, MD, PhD
    The Parkinson's Institute, Sunnyvale, California

CDE Steering Committee Members 2011-Present (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
  • Michael D'Andrea, PhD
    Coriell Institute, Camden, New Jersey
  • Michael Feolo, MS
    National Center for Biotechnology Information, Bethesda, Maryland
  • Bron Kisler
    Clinical Data Interchange Standards Consortium (CDISC), Austin, Texas
  • Naomi Kleitman, PhD
    Craig H. Neilsen Foundation, Encino, California
  • Matthew McAuliffe, PhD
    Federal Interagency Traumatic Brain Injury Research Project, Bethesda, Maryland
  • Erin Ramos, PhD, MPH
    National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH), Bethesda, Maryland
  • Yaffa Rubinstein, PhD
    National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH), Bethesda, Maryland
  • Chi Tarn, PhD
    Coriell Institute for Medical Research, Camden, New Jersey

CDE Steering Committee Members 2006-2010

  • Roderick Corriveau, PhD
    Coriell Institute for Medical Research, Camden, New Jersey
  • Gary Cutter, PhD
    University of Alabama School of Public Health, Birmingham, Alabama
  • 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 Colombia
  • Karl Kieburtz, MD, MPH
    University of Rochester, Rochester, New York
  • Roger Kurlan, MD
    University of Rochester, Rochester, New York
  • Andrew Maas, MD, PhD
    University Hospital Antwerp, Edegem, Belgium
  • Yuko Palesch, PhD
    Medical University of South Carolina, Charleston, South Carolina
  • Ralph Sacco, MD, MS
    University of Miami, Miller School of Medicine, Miami, Florida
  • Barbara Tilley, PhD
    University of Texas School of Public Health, Austin, Texas

NINDS CDE Team

  • M. Carolina Mendoza-Puccini, MD
    Scientific Program Specialist, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i, MS
    The Emmes Corporation
  • Joy Esterlitz, MS
    The Emmes Corporation

References

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