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 Amyotrophic Lateral Sclerosis
(ALS) CDE CRF modules can be downloaded below.
Download ALS 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
|
61KB DOC |
HTML |
|
| Social Status |
| Social Status
|
57KB DOC |
HTML |
|
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Participant/Subject History and Family History
Participant/Subject History and Family History
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| General Health History |
| Medical History
|
75KB DOC |
HTML |
|
| Family History
|
81KB DOC |
HTML |
|
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Disease/Injury Related Events
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Classification |
| Symptom, Sign, Diagnosis Criteria
|
57KB DOC |
HTML |
|
| Genetics
|
38KB 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 Examination
|
81KB DOC |
HTML |
|
| Neuromuscular Examination
|
145KB DOC |
HTML |
|
| Vital Signs and Other Body Measures |
| Vital Signs
|
63KB DOC |
HTML |
|
| Laboratory Tests and Biospecimens/Biomarkers |
| Laboratory Tests
|
370KB DOC |
HTML |
|
| Tissue Based Marker Collection
|
37KB DOC |
HTML |
|
| Fasting Information
|
42KB DOC |
HTML |
|
| Resting Energy Expenditure
|
22KB DOC |
HTML |
|
| Collection of Fluid: Blood Guidelines
|
46KB DOC |
N/A |
|
| Collection of Fluid: Plasma Guidelines
|
43KB DOC |
N/A |
|
| Collection of Fluid: CSF Guidelines
|
43KB DOC |
N/A |
|
| Collection of Fluid: Urine Guidelines
|
35KB DOC |
N/A |
|
| Biomarkers Other Collection Information Guidelines
|
36KB DOC |
N/A |
|
| Imaging Diagnostics |
| Brain Perfusion Magnetic Resonance Imaging
|
54KB DOC |
HTML |
|
| Diffusion Tensor Imaging (DTI)
|
50KB DOC |
HTML |
|
| Functional Magnetic Resonance Imaging (fMRI)
|
52KB DOC |
HTML |
|
| Magnetic Resonance Imaging (MRI)
|
69KB DOC |
HTML |
|
| Magnetic Resonance Spectroscopy
|
54KB DOC |
HTML |
|
| Non-Imaging Diagnostics |
| Electrophysiology
|
203KB DOC |
HTML |
|
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Treatment/Intervention Data
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Treatment/Intervention Data
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| Drugs |
| Prior and Concomitant Medications
|
47KB DOC |
HTML |
|
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Protocol Experience
Note: The General CDE Standards contain useful CRF Modules and CDEs for this domain.
Safety Data
Note: The General CDE Standards contain useful CRF Modules and CDEs for this domain.
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.
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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 et al. 2007).
Posner, K, MA Oquendo, M Gould, B Stanley, and M Davies, 2007, Columbia Classification
Algorithm of Suicide Assessment
(C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk
Analysis of Antidepressants, Am J Psychiatry, 164:1035-1043.
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 Amyotrophic Lateral Sclerosis CDE Working Group is currently comprised of four
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 ALS CDE Working Group is supported by
the NINDS CDE Team. The complete ALS CDE Working Group
roster and the rosters by Subgroup are shown below.
Complete Amyotrophic Lateral Sclerosis CDE Working
Group Roster 
The Working Group members serve on either one or two subgroups. The subgroups began
meeting by teleconference in November 2010 and continued to hold calls every four
to six weeks through spring 2011 to define the CDEs for their domains and to recommend
standardized, validated instruments for ALS research.
Working Group Co-Chairs
- James Caress, MD - Wake Forest University
- Lucie Bruijn, PhD - ALS Association
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Biomarkers/ Imaging
- Robert Bowser, PhD - University of Pittsburgh School of Medicine, Chair
- Michael Benatar, MS, DPhil - University of Miami Hospital
- Jonathan Glass, MD - Emory University School of Medicine
- Varan Govind, PhD - University of Miami School of Medicine
- Vincent Meininger, MD, PhD - Fédération des Maladies du Système Nerveux, Hôpital de la Salpêtrière
- Hiroshi Mitsumoto, MD - Columbia University Motor Neuron Center
- Jeremy Shefner, MD, PhD - Upstate Medical University
- Alexander Sherman, MD - Massachusetts General Hospital
- Martin Turner, PhD - Oxford University
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Clinical Research/ Quality of Life (QOL)
- Merit Cudkowicz, MD, MSc - Massachusetts General Hospital, Chair
- Stanley Appel, MD - The Methodist Hospital Research Institute, Weill Cornell Medical College
- Richard Barohn, MD - Kansas University Medical Center
- Michael Benatar, MS, DPhil - University of Miami Hospital
- Frank Bennett, PhD - Isis Pharaceuticals
- Kathie Bishop, PhD - Isis Pharaceuticals
- Benjamin Rix Brooks, MD - Carolinas Medical Center
- Jesse Cedarbaum, MD - Cytokinetics
- Valerie Cwik, MD - Muscular Dystrophy Association
- Julaine Florence, PhD, DPT - Washington University School of Medicine
- Orla Hardiman, MD - Trinity College Institute of Neuroscience
- Laura Herbelin, CCRP - University of Kansas Medical Center
- Edward Kasarskis, MD, PhD - University of Kentucky College of Medicine, Veterans Affairs Medical Center
- Wendy King, PT - Ohio State University
- Zachary Simmons, MD - Penn State Hershey Medical Center
- Richard Smith, MD - University of California San Diego, Center for Neurological Study
- Eric Sorensen, MD - Mayo Clinical Rochester, Great Lakes ALS
- Hong Yu, MPH - Massachusetts General Hospital
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Cognitive/ Frontotemporal Dementia (FTD)
- Catherine Lomen-Hoerth, MD, PhD - University of California San Francisco, Co-Chair
- Zachary Simmons, MD - Penn State Hershey Medical Center, Co-Chair
- Sharon Abrahams, PhD - University of Edinburgh
- Richard Buchsbaum - Columbia University Mailman School of Public Health
- Lora Clawson, MSN, CRNP - Johns Hopkins Hospital
- Laura Goldstein, PhD - King's College London
- Murray Grossman, MD, EdD - University of Pennsylvania School of Medicine
- Dan Moore, PhD - Univeristy of California San Francisco, California Pacific Medical Center
- Jennifer Murphy, PhD - University of Califonia San Francisco
- Seamus Thompson, PhD - Columbia University Mailman School of Public Health
- Susan Woolley, PhD - Forbes Norris ALS Research Center
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Genetics
- Bryan Traynor, MD, MMSc - National Institute on Aging, Johns Hospkins Medical Center, Chair
- Leonard van den Berg, MD, PhD - University Medical Center Urecht
- Robert Brown, MD - University of Massachusetts Amherst
- Adriano Chio, MD - University of Torino, AOU San Giovanni Battista
- Vivian Drory, MD - Tel-Aviv Sourasky Medical Center
- Karen Morrison, PhD - University of Birmingham
- Rosa Rademakers, PhD - Mayo Clinic College of Medicine
- Kevin Talbot, MD, DPhil - Oxford University
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NINDS CDE Team
- Robin Conwit, MD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Amelie Gubitz, PhD - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Petra Kaufmann, MD, MSc - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joanne Odenkirchen, MPH - National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
- Joshua Hagel - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
- Pamela West - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
- Lisa Hunegs, MSW, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)
- Kristy Miller, MPH - KAI Research, Inc. (An Altarum Company), Rockville, Maryland, USA (2007 - 2012)
- Megan Schmidt - 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.