Organized into domains often used in clinical studies, data standards
include:
- CDEs
- CRF Modules logically organize CDEs for data collection
- Guidelines to provide further information about the CDEs.
- Recommended Instruments spreadsheets with details (descriptions,
scoring, references, etc.) for all recommended proprietary instruments/ scales/
tests. If proprietary instruments/scales/tests are made available for use, they
are populated in the table below.
For your reference, a zip file containing all of the Epilepsy CDE CRF modules can
be downloaded below.
Download Epilepsy CDE Recommendations
The outline that follows includes all the CDEs associated with the CRF modules,
organized by domain and sub-domain.
Participant/Subject Characteristics
Participant/Subject Characteristics
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Demographics |
| Demographics
|
60KB DOC |
HTML |
|
| Social Status |
| Social Status
|
69KB DOC |
HTML |
|
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Participant/Subject History and Family History
Note: The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Disease/Injury Related Events
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Classification |
| Classification of Seizures
|
90KB DOC |
HTML |
|
| Classification of Etiology
|
96KB DOC |
HTML |
|
| Syndromes by Age of Onset
|
132KB DOC |
HTML |
|
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Assessments and Examinations
Assessments and Examinations
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Physical/Neurological Examination |
| Physical Exam
|
63KB DOC |
HTML |
|
| Neurological Exam
|
160KB DOC |
HTML |
|
| Vital Signs and Other Body Measures |
| Vital Signs
|
67KB DOC |
HTML |
|
Laboratory Tests and Biospecimens/BiomarkersNote: The General CDE Standards contain additional useful CRF Modules and CDEs for this sub-domain. |
| NINDS Repository Epilepsy Data Elements
|
NINDS-Coriell  |
N/A |
|
| Imaging Diagnostics |
| Functional Magnetic Resonance Imaging (fMRI)
|
61KB DOC |
HTML |
|
| Ictal Single-photon Emission Computed Tomography (SPECT) Localization
|
84KB DOC |
HTML |
|
| Magnetoencephalography (MEG) Acquisition
|
64KB DOC |
HTML |
|
| Magnetic Resonance Imaging (MRI)
|
116KB DOC |
HTML |
|
| MRI for Registration of MEG
|
58KB DOC |
N/A |
|
| Positron Emission Tomography (PET) Localization
|
89KB DOC |
HTML |
|
| Non-Imaging Diagnostics |
| Scalp Electroencephalography (EEG)
|
206KB DOC |
HTML |
|
| Short Scalp Electroencephalography (EEG)
|
60KB DOC |
HTML |
|
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Treatment/Intervention Data
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Protocol Experience
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Safety Data
The CDEs from copyright-protected measures are intentionally excluded from this site unless permission was received from the copyright holder. If the measure is not included, please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Safety Data
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Adverse Events |
| Adverse Event Tracking Log
|
64KB DOC |
HTML |
|
| Overview of Recommended Adverse Event Reporting Instruments
|
33KB DOC |
N/A |
|
| Recommended Adverse Event Reporting Instruments
|
80KB DOC |
N/A |
|
| Hague Side Effects Scale
|
47KB DOC |
HTML |
 |
| VA Toxicity Scale
|
81KB DOC |
HTML |
|
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Outcomes and End Points
The CDEs from copyright-protected measures are intentionally excluded from this site unless permission was received from the copyright holder. If the measure is not included, please contact the publisher or person who holds the copyright to obtain a copy of the measure.
Outcomes and End Points
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Assessing Comorbidities |
| Overview of Instruments for Assessing Comorbidities
|
56KB DOC |
N/A |
|
| Recommended Cognitive Instruments
|
45KB DOC |
N/A |
|
| Recommended Psychiatric Instruments
|
DOC |
N/A |
|
| Recommended Migraine Instruments
|
34KB DOC |
N/A |
|
| Adult ADHD Self-Report Scale (ASRS)
|
145KB PDF |
HTML |
|
| American National Adult Reading Test (AmNART)
|
77KB PDF |
HTML |
|
| Checklist for Autism in Toddlers (CHAT)
|
52KB DOC |
HTML |
|
| Headache Screening Survey
|
261KB PDF |
HTML |
|
| Longitudinal Interval Follow-Up Evaluation DSM-IV VERSION (LIFE DSM-IV)
|
459KB PDF |
HTML |
|
| Patient Health Questionnaire-9 (PHQ-9)
|
39KB PDF |
HTML |
|
| Patient Health Questionnaire Generalized Anxiety disorder (GAD-7)
|
29KB PDF |
HTML |
|
| Neuropsychological Testing |
| Overview of Recommended Neuropsychology Instruments
|
82KB DOC |
N/A |
|
| Recommended Neuropsychology Instruments - Adult
|
214KB DOC |
N/A |
|
| Recommended Neuropsychology Instruments - Pediatric
|
249KB DOC |
N/A |
|
| Neuropsychological Testing Background Information
|
59KB DOC |
HTML |
|
| Patient Reported Outcomes |
| Seizure Diary
|
69KB DOC |
HTML |
|
| Quality of Life |
| Overview of Recommended Quality of Life Instruments
|
DOC |
N/A |
|
| Recommended Quality of Life Instruments - Adult
|
71KB DOC |
N/A |
|
| Recommended Quality of Life Instruments - Pediatric
|
DOC |
N/A |
|
| Neuro-QOL Instruments Summary
|
108KB DOC |
N/A |
|
| Healthy Days Core Module (CDC HRQOL-4)
|
41KB DOC |
HTML |
|
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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
http://www.cssrs.columbia.edu, see additional C-SSRS information for
background materials provided to the NINDS CDE project by Dr. Posner) or another
instrument that maps to the Columbia Classification Algorithm for Suicide Assessment
(C-CASA) (Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Am J Psychiatry. 2007 Columbia Classification Algorithm of
Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Jul;164(7):1035-43. PMID: 17606655).
Accessibility Statement
The NINDS CDE Team has requested, and in many cases received, permission to post
proprietary instruments/scales recommended by the CDE Working Groups to this site.
When permission is granted, the documents are posted in the exact format they were
received in order to maintain the validity of the instrument. If approval is not
granted for the instrument to be reproduced on this site, with the author/copyright
holder’s permission, a link is posted to an external Web site where users can get
more information about the instrument. If you have difficulty accessing either the
proprietary instruments/scales or the external links, please contact the
NINDS CDE Project Officer, Joanne Odenkirchen.
Download readers:
The Epilepsy Common Data Elements (CDEs) follow the recommendations of the
Epilepsy CDE Working Group (WG), a committee of experts in the field (see
History and Acknowledgements).
The NINDS recognizes that the Epilepsy CDEs are dynamic tools that will continue
to evolve over time. Consequently, the Epilepsy CDEs will be periodically reviewed
and updated based on feedback from the epilepsy community and changes in the clinical
research landscape.
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
presented are organized into domains which are intuitive and common in clinical
research studies.
Download a “checklist” – Checklist for Epilepsy Clinical Trials
OR Checklist for Other Epilepsy Clinical
Studies
– to
help locate the CRF Modules in the Data Standards. Each checklist provides an outline
of the CRF Modules that may be needed for an Epilepsy clinical trial/ other type
of clinical study.
The Epilepsy CDE Working Group (WG) first convened in December 2009 and divided
into subgroups to focus on identifying and defining data elements across epilepsy
domains. WG members served on either one or two subgroups. Subgroup conference calls
began in April 2009 and continued every four to six weeks through the spring of
2010. The subgroups of the Epilepsy CDE WG took a couple different approaches. Some
groups opted to define the CDEs by creating template data collection form(s) and
others decided it was more appropriate to recommend standardized, validated instruments
for specific domains of epilepsy research.
The Epilepsy CDE Working Group is currently comprised of nine different subgroups.
Chairs were appointed to lead the overall Working Group and the individual subgroups.
The Working Group members actively develop the CDEs for their specific subgroups
and also have an opportunity to review and comment on the recommendations of the
other subgroups. The Epilepsy CDE Working Group is supported by the
NINDS CDE Team. The complete Epilepsy CDE Working Group roster and the rosters
by Subgroup are shown below.
Complete Epilepsy CDE Working
Group Roster 
Working Group Co-Chairs
- Nicholas Barbaro, MD - University of California, San Francisco
- Daniel Lowenstein, MD - University of California, San Francisco
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Anti Epileptic Drugs (AEDs) and Other Anti Epileptic Treatments (AETs) Subgroup
- Jackie French, MD - New York University, Chair
- Peggy Clark, RN, MSN - Cincinnati Children's Hospital Medical Center
- James Cloyd, PharmD - University of Minnesota
- Tracy Glauser, MD - Cincinnati Children's Hospital Medical Center
- Nina Graves, PharmD - Medtronic
- Daniel Lowenstein, MD - University of California, San Francisco
- Gerry Nesbitt, MBA - University of California, San Francisco
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Comorbidities Subgroup
- Bruce Hermann, PhD - University of Wisconsin, Chair
- Joan Austin, DNS, RN, FAAN - Indiana University
- Anne Berg, PhD - BIOS Northern Illinois University
- Anne Van Cott, MD - U.S. Department of Veterans Affairs, University of Pittsburgh
- Kristen Fowler, MA - Beth Israel Deaconess Medical Center, Harvard Medical School
- Tracy Glauser, MD - Cincinnati Children’s Hospital Medical Center
- Allen Hauser, MD - Columbia University
- Dale Hesdorffer, PhD - Columbia University
- Curt LaFrance, MD - Rhode Island Hospital
- Ruth Ottman, PhD - Columbia University
- Shlomo Shinnar, MD - Montefiore Medical Center
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Electrophysiology Subgroup
- Anne Van Cott, MD - U.S. Department of Veterans Affairs, University of Pittsburgh, Chair
- Dennis Dlugos, MD - Children's Hospital of Philadelphia
- William Gaillard, MD - Children's National Medical Center
- Gerry Nesbitt, MBA - University of California, San Francisco
- Susan Spencer, MD - Yale School of Medicine
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Imaging Subgroup
- William Gaillard, MD - Children's National Medical Center, Chair
- Nicholas Barbaro, MD - University of California, San Francisco
- Gregory Barkley, MD - Henry Ford Hospital Clinics
- Robert Knowlton, MD, MSPH - University of Alabama at Birmingham
- Ruben Kuzniecky, MD - New York University
- Susan Spencer, MD - Yale School of Medicine
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Neurological Exam Subgroup
- Dennis Dlugos, MD, MSCE - Children's Hospital of Philadelphia, Chair
- Peggy Clark, RN, MSN - Cincinnati Children's Hospital Medical Center
- Daniel Lowenstein, MD - University of California, San Francisco
- Christine O’Dell, RN, MSN - Montefiore Medical Center
- David Thurman, MD - National Center for Chronic Disease Prevention and Health Promotion
- Mariann Ward, MS, NP - University of California, San Francisco
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Neuropsychology Subgroup
- David Loring, PhD - Emory University, Chair
- Avital Cnaan, PhD - Children's National Medical Center
- Marla Hamberger, PhD - Columbia University
- Bruce Hermann, PhD - University of Wisconsin
- John Langfitt, PhD - University of Rochester
- Elisabeth Sherman, PhD - Alberta Children’s Hospital
- Mary Lou Smith, PhD - University of Toronto Mississauga and Hospital for Sick Children
- Michael Westerveld, PhD - Yale University
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Quality of Life Subgroup
- Joan Austin, DNS, RN, FAAN - Indiana University, Chair
- David Cella, PhD - Northwestern University
- Avital Cnaan, PhD - Children's National Medical Center
- Kristen Fowler, MA - Beth Israel Deaconess Medical Center, Harvard Medical School
- Marla Hamberger, PhD - Columbia University
- John Langfitt, PhD - University of Rochester
- Christine O'Dell, RN, MSN - Montefiore Medical Center
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Seizures and Syndromes Subgroup
- Dale Hesdorffer, PhD - Columbia University, Chair
- Anne Berg, PhD - BIOS Northern Illinois University
- Jackie French, MD - New York University
- Allen Hauser, MD - Columbia University
- Shlomo Shinnar, MD, PhD - Montefire Medical Center
- David Thurman, MD - National Center for Chronic Disease Prevention and Health Promotion
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Surgery and Pathology Subgroup
- Steven Roper, MD - University of Florida, Chair
- Nicholas Barbaro, MD - University of California, San Francisco
- Robert Fisher, MD, PhD - Stanford University
- Susan Spencer, MD - Yale School of Medicine
- Samuel Wiebe, MD - Foothills Medical Center
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NINDS CDE Team
- Brandy Fureman, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) (February 2009 - present)
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) (September 2009 - present)
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
- Pamela West - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
- Margaret Jacobs - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH) (2007 - February 2009)
- Stacie Grinnon, MS - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)
- Alexandra Stout - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)
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Note: Institutions for all individuals acknowledged in this section
were those they belonged to when they joined the Committee. All Committee
members were asked to voluntarily disclose all potential sources of bias in their
involvement with the NINDS CDE Project. The summary disclosure information is available
upon request by contacting NINDSCDE@emmes.com.
The Epilepsy CDEs were most recently revised in June 2013. The Word document below describes all the revisions incorporated into the Epilepsy CDEs since Version 1.0 was originally released.
Please contact NINDSCDE@emmes.com if you require further information or have
any questions about the revision history.
Epilepsy
CDEs Revision History - June 2013