Headache

Data Standards

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

•         CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory

•         CRF Modules — Template forms that logically organize CDEs for data collection

•         Guidance Documents — Provide further information about the CDEs

•         Instrument Notice of Copyright (NOC) Documents Include pertinent information on recommended instruments

Headache Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Headache study start-up

Headache Highlight Summary: Overview of all Headache-specific CDE recommendations as they appear on the website

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.

Helpful Hints:

Once you have completed your search, the search results will need to be expanded by clicking the Expand All button to view results.

The default setting for each field is ‘Any’.

When searching on the Traumatic Brain Injury or Sports Related Concussion disorder pages selecting a Timeframe or Sub-Disease will return more specific results.

For best results, click the Clear button between searches.

Please contact NINDS CDE team (NINDSCDE@emmes.com) in case you encounter any search difficulties.

Click here for additional instructions

Search Term(s)
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
Treatment/Intervention Data
Outcomes and End Points
Cognitive Status
CRF Module/Guidance CDEs
Mig S-Cog N/A

Overview

The first set of Common Data Elements (CDEs) for Headache were developed in 2011. In June 2017, the Headache CDE Working Group finished their work on version 2.0 of the Headache CDEs.

To develop the Headache v2.0 CDEs, the Headache Version 2.0 CDE Working Group divided into five (5) subgroups to focus on identifying and defining data elements in the domains of:

  • Biomarkers
  • Demographics
  • Diagnostics and Characteristics
  • Imaging and Neurophysiology
  • Therapies and Interventions

Roster

The Headache Version 2.0 CDE Working Group was comprised of five (5) different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. 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 Headache CDE Working Group was supported by the NINDS CDE Team. The complete Headache CDE Version 2.0 Working Group roster by subgroup are shown below.

Complete Version 1.0 Headache CDE Working Group Roster

Biomarkers Version 2.0

  • Michael Harrington, MB, ChB, FRCP
    Huntington Medical Research Institutes, Pasadena, California
    Co-Chair
  • B. Lee Peterlin, DO
    Johns Hopkins University, Baltimore, Maryland
    Co-Chair
  • Angel L. Guerrero, MD, PhD
    University Clinical Hospital of Valladolid, Valladolid, Spain
  • Andrew Hershey, MD, PhD, FAHS
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Timothy Houle, PhD
    Wake Forest University School of Medicine, Winston-Salem, North Carolina
  • Gisela Terwindt, MD, PhD
    Leiden Headache Research Group, Leiden, Netherlands
  • Gretchen Tietjen, MD
    University of Toledo, Toledo, Ohio
  • Arn M.J.M. van den Maagdenberg, PhD
    Leiden University Medical Center, Leiden, Netherlands
  • Gerrit L.J. Onderwater, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands
  • Robin van Dongen, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands
  • Irene de Boer, MD
    (AdHoc Member) Leiden Headache Research Group, Leiden, Netherlands

Demographics Version 2.0

  • Ann Scher, PhD
    Uniformed Services University of the Health<br />Sciences (USUHS), Bethesda, Maryland
    Chair
  • Lenore Launer, PhD
    National Institute of Health (NIH), Bethesda, Maryland
  • Kathleen Merikangas, PhD
    National Institute of Mental Health (NIMH), Bethesda, Maryland
  • Elizabeth Seng, PhD
    Yeshiva University, Bronx, New York
  • Todd Smitherman, MS, PhD
    University of Mississippi, University, Mississippi

Diagnostics and Characteristics Version 2.0

  • David Dodick, MD
    Mayo Clinic, Phoenix, Arizona
    Co-Chair
  • Stephen Silberstein, MD, FACP
    Thomas Jefferson University, Philadelphia, Pennsylvania
    Co-Chair
  • Andrew Ahn, MD, PhD
    Eli Lilly and Company, Indianapolis, Indiana
  • Sheena Aurora, MD
    Eli Lilly and Company, Indianapolis, Indiana
  • Michel Lanteri-Minet, MD
    C.H.U. Hopital Pasteur, Nice, France
  • Sagar Munjal, MD, MS
    Dr. Reddy's Laboratories Inc, Princeton, New Jersey
  • Eric M. Pearlman, MD, PhD
    Eli Lilly and Company, Indianapolis, Indiana
  • Donald Penzien, PhD
    University of Mississippi Medical Center, Jackson, Mississippi
  • Caryn Seebach, PsyD
    Jefferson Headache Center, Philadelphia, Pennsylvania
  • Nicole M. Spare, DO
    Jefferson Headache Center, Philadelphia, Pennsylvania
  • Christina Szperka, MD, MSCE
    Children's Hospital of Philadelphia, Philadelphia, PA
  • Hsiangkuo Scott Yuan, MD, PhD
    Jefferson Headache Center, Philadelphia, Pennsylvania

Imaging and Neurophysiology Version 2.0

  • Todd Schwedt, MD, MSCI
    Mayo Clinic, Phoenix, Arizona
    Chair
  • Hans-Christoph Diener, MD, PhD, FAHA, FAAN
    University Duisburg-Essen, Duisburg and Essen, North Rhine-Westphalia, Germany
  • Manjit Matharu, MRCP, PhD
    National Hospital for Neurology and Neurosurgery, London, United Kingdom
  • Scott Powers, PhD, ABPP
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Jean Schoenen, MD, PhD
    University of Liege, Liege, Wallonia, Belgium
  • Jing Xiang, MD, PhD
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio

Therapies and Interventions Version 2.0

  • David Dodick, MD
    Mayo Clinic, Phoenix, Arizona
    Co-Chair
  • Stephen Silberstein, MD, FACP
    Thomas Jefferson University, Philadelphia, Pennsylvania
    Co-Chair
  • Aftab Alam, MD, MBA
    Dr. Reddy's Laboratories Inc, Princeton, New Jersey
  • Ernesto Aycardi, MD
    Teva Pharmaceuticals, Cambridge, Massachusetts
  • David Borsook, MD
    Children's Hospital, Belmont, Massachusetts
  • Mitchell Brin, MD, FAAN
    Allergan, Irvine, California
  • Roger Cady, MD, FAHS
    Alder BioPharmaceuticals Inc, Bothell, Washington
  • Benjamin Friedman, MD, MS, FAAEM
    Montefiore Medical Center, Bronx, New York
  • Peter Goadsby, MD, PhD
    University of California, San Francisco, San Francisco, California
  • Scott Powers, PhD, ABPP
    Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio
  • Michael Rapoff, PhD
    University of Kansas Medical Center, Kansas City, Kansas
  • Uwe Reuter, MD
    The Headache Clinic of the Charite, Berlin, Germany
  • William Young, MD, FAHS, FAAN
    Thomas Jefferson University, Philadelphia, Pennsylvania

NINDS CDE Team

  • M. Carolina Mendoza-Puccini, MD
    NINDS CDE Program Officer, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Michael L. Oshinsky, PhD
    National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, Maryland
  • Sherita Ala'i Hansen, MS (Until 2018)
    The Emmes Company, LLC, Rockville, Maryland
  • Joy Esterlitz, MS (Until 2020)
    The Emmes Company, LLC, Rockville, Maryland
  • Katelyn Gay, BS
    The Emmes Company, LLC, Rockville, Maryland
  • Aria Lans, MPH
    The Emmes Company, LLC, Rockville, Maryland
  • Muniza Sheikh, MS, MBA
    The Emmes Company, LLC, Rockville, Maryland
  • Amanda Suller, BS (Until 2015)
    The Emmes Company, LLC, Rockville, Maryland
  • Sarah Tanveer, BS
    The Emmes Company, LLC, Rockville, Maryland

Publications

A publication related to the Headache CDE initiative is in development. The citation for this publication will be included on this site as soon as it is available.

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.

Headache CDEs Revision History