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 the current HD CDE template CRF modules
can be downloaded below.
Download HD 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
|
65KB DOC |
HTML |
|
| Social Status |
| Social Status
|
51KB DOC |
HTML |
|
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Participant/Subject History and Family History
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Disease/Injury Related Events
Disease/Injury Related Events
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
| History of Disease/Injury Event |
| Medical History of Huntington's Disease
|
90KB DOC |
HTML |
|
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Assessments and Examinations
Assessments and Examinations
| CRF Module/Guideline by Sub-Domain |
Download |
CDEs |
© or TM |
Physical/Neurological ExaminationNote: The General CDE Standards contain additional useful CRF Modules and CDEs for this sub-domain. |
Vital Signs and Other Body MeasuresNote: The General CDE Standards contain additional useful CRF Modules and CDEs for this sub-domain. |
Laboratory Tests and Biospecimens/BiomarkersNote: The General CDE Standards contain additional useful CRF Modules and CDEs for this sub-domain. |
| NINDS Repository Huntington's Disease Data Elements
|
NINDS-Coriell  |
N/A |
|
| DNA Elements - Information from the Laboratory
|
35KB DOC |
HTML |
|
| DNA Elements - Information from the Study Investigator
|
39KB DOC |
HTML |
|
| DNA Elements - Participant/Subject Information
|
39KB DOC |
HTML |
|
| Blood Collection and Processing Guidelines
|
123KB DOC |
N/A |
|
| CSF Collection and Processing Guidelines
|
70KB DOC |
N/A |
|
| Urine Collection and Processing Guidelines
|
68KB DOC |
N/A |
|
| Solid Tissue Collection Guidelines
|
86KB DOC |
N/A |
|
| Other Biological Specimens Collection Guidelines
|
67KB DOC |
N/A |
|
| Imaging Diagnostics |
| Magnetic Resonance (MR) Localization Imaging
|
112KB DOC |
HTML |
|
| Other Clinical Data |
| Neuropathology Data Form
|
766KB DOC |
HTML |
|
| Preparation of Brains for Stereological Evaluation Guidelines
|
47KB DOC |
N/A |
|
| HD Brain Processing Guidelines
|
6610KB PPT |
N/A |
|
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Treatment/Intervention Data
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Protocol Experience
Note: The General CDE Standards contain additional useful CRF Modules and CDEs for this domain.
Safety Data
Note: The General CDE Standards contain additional 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 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 Huntington’s Disease CDE Working Group is currently comprised of eleven 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 HD CDE Working Group is supported by the
NINDS CDE Team. The complete HD CDE Working Group roster and the rosters
by Subgroup are shown below.
Complete Huntington’s Disease CDE Working
Group Roster 
The Working Group members serve on one subgroup. The subgroups began meeting by
teleconference in March 2011 and continued to hold calls every four to six weeks
through fall 2011 to define the CDEs for their domains and to recommend standardized,
validated instruments for HD research.
Working Group Co-Chairs
- Ira Shoulson, MD - Georgetown University
- Julie Stout, PhD - Monash University
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Behavior/Psychiatry
- Karen Anderson, MD - University of Maryland School of Medicine, Chair
- David Craufurd, MB, BS, MSc, FRCPsych - The University of Manchester School of Medicine
- Erik van Duijn, MD, PhD - Leiden University Medical Center
- Mark Groves, MD - Beth Israel Medical Center, Phillips Ambulatory Care Center
- Daniel van Kammen, MD, PhD -
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Biochemical Markers
- Blair Leavitt, MD, CM, FRCPC - The University of British Columbia, BC Children's Hospital, Chair
- Beth Borowsky, PhD - CHDI Foundation, Inc.
- Steven Hersch, MD, PhD - Massachusetts General Hospital, Harvard Medical School
- Ruth Luthi-Carter, PhD - École Polytechnique Fédérale de Lausanne
- Oksana Suchowersky, MD, PhD, FRCP - University of Calgary
- Sarah Tabrizi, MD, PhD, FRCP - UCL Institute of Neurology, National Hospital of Neurology and Neurosurgery
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Cognitive
- Jennifer Thompson, PhD - Greater Manchester Neuroscience Centre, Chair
- Leigh Beglinger, PhD - University of Iowa, Carver College of Medicine
- Peter Como, PhD - U.S. Food and Drug Administration
- Deborah Harrington, Ph.D - University of California San Diego, Ad hoc member
- Sarah Queller, PhD - Queller Consulting
- Megan Smith, Ph.D - The University of Iowa, Ad hoc member
- Glenn Stebbins, PhD - Rush University, Rush Medical College
- Julie Stout, PhD - Monash University
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Epidemiology/Environment
- Carolyn Tanner, MD, PhD - The Parkinson's Institute, Chair
- Monica Busse, PhD - Cardiff University
- Elan Louis, MD, MSc - Columbia University, Mailman School of Public Health
- Karen Marder, MD, MPH - Columbia University, College of Physicians and Surgeons
- Brad Racette, MD - Washington University School of Medicine
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Functional Outcomes/Patient Reported Outcomes
- Jody Corey-Bloom, MD, PhD - University of California San Diego, Chair
- Noelle Carlozzi, PhD - The Center for Rehabilitation Outcomes and Assessment Research, University of Michigan
- Aileen Ho, PhD - University of Reading, Earley Gate
- Bernhard Landwehrmeyer, MD, PhD - University of Ulm
- Jane Paulsen, PhD - University of Iowa, Carver College of Medicine
- Lori Quinn, PT, EdD - Cardiff University
- David Tulsky, Ph.D. - University of Michigan Medical School
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Genetics
- Tatiana Foroud, PhD - Indiana University School of Medicine, Chair
- James Gusella, PhD - Massachusetts General Hospital, Center for Human Genetic Research
- Lesley Jones, PhD - Cardiff University School of Medicine
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Imaging Biomarkers
- Elizabeth Aylward, PhD - Seattle Children's Research Institute, Chair
- Andrew Feigin, MD - New York University School of Medicine
- Nellie Georgiou-Karistianis, PhD - Monash University
- Diana Rosas, MD - Massachusetts General Hospital
- Christopher Ross, MD, PhD - The Johns Hopkins University
- Rachel Scahill, MA, PhD - UCL Institute of Neurology
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Motor
- Kevin Biglan, MD - University of Rochester School of Medicine and Dentistry, Chair
- Joanne Fielding, PhD - Monash Medical Centre
- Joseph Jankovic, MD - Baylor College of Medicine
- Ralf Reilmann, MD - University Clinic Muenster
- Kathleen Shannon, MD - Rush University Medical Center
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Operations
- Elise Kayson, MS, RNC, ANP - University of Rochester, Chair
- Lisa deBlieck, MPA, CCRC - University of Rochester
- Terry Tempkin, RNC, MSN, ANP - University of California Davis Medical Center
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Pathology
- Jean Paul Vonsattel, PhD - Children's Hospital of New York-Presbyterian, Chair
- Marian DiFiglia, MD, PhD - Massachusetts General Hospital
- Carol Moskowitz, MS, APRN-C, CNRN - Columbia University HD Center
- Raymund Roos, MD - Leiden University Medical Center
- Clifford Saper, MD, PhD - Harvard Medical School and Beth Israel Deaconess Medical Center
- Leslie Thompson, PhD - University of California, Irvine
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Scale Metrics and Statistics
- Doug Langbehn, MD, PhD - University of Iowa, Carver College of Medicine, Chair
- Peggy Auinger, M.S. - University of Rochester
- Kenneth Evans, PhD - Ontario Cancer Biomarker Network
- Michael McDermott, PhD - University of Rochester Medical Center
- John Warner, PhD - CHDI Foundation, Inc.
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NINDS CDE Team
- Wendy Galpern, MD, 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)
- Sarah Duwel, RN, MA - The EMMES Corporation, Rockville, Maryland, USA (2013 - present)
- Angela Soriano - 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.
The Huntington’s Disease CDEs were most recently revised in October 2012. The document
below describes all the revisions incorporated in the October 2012 version compared
to the original version dated May 2012. Please contact
NINDSCDE@emmes.com if you require further information or have
any questions about the revision history.
HD CDEs
Revision History - October 2012