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Introduction to NINDS CDE Web site

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Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





The NINDS Common Data Element (CDE) Web site includes all of the CDE products to date as well

as additional information about the CDE Project. NINDS will continue to update the site with

additional CDE materials (e.g., data dictionaries, template forms, etc.) and other updates as they

become available.









Home page (shown above)



The NINDS CDE Web site Home page provides users with a brief overview and birds-eye view of the

resources and tools available on the Web site.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Navigation links/Portals:



Hyperlinks located on the bottom of the Home page (see figure below) provide users access to the Web site’s three main sections or

portals:



 Standards pages - Start here to find the CDE standard sets that can be incorporated into your studies. This resource is divided into

disease specific standards as well as the General CDEs.



 Tools pages- Experienced users can employ these tools to help assemble their data collection materials. These are designed to

provide additional resources to those individuals with data management and/or database experience.



 Learn pages - Provides additional details about the CDE Project and how data elements are designated as NINDS CDEs. Tutorials

will eventually be added to this portal.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





A menu on the right side of the Home page displays the CDEs (both general and disease-specific) that are available for use as well as those

that are currently being developed by the NINDS CDE Project.









The CDEs currently available

include: General (Core- updated

Feb 2011), Epilepsy, Parkinson’s

Disease (newly released Feb 2011),

Spinal Cord Injury, Stroke and

Traumatic Brain Injury (TBI).









The additional disease-specific

standards shown to the bottom left are

currently in development.



The following CDEs will be added to

this Web site as soon as they become

available: Frontotemporal Dementia

(FTD) CDEs; Headache CDEs;

Huntington’s Disease (HD) CDEs;

Amyotrophic Lateral Sclerosis (ALS)

CDEs; Congenital Muscular Dystrophy

CDEs; Friedreich's Ataxia CDEs; Multiple

Sclerosis; and additional CDEs for other

Neuromuscular Diseases

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Portal Tabs (shown below)



Navigate around the site using the tabs located at the top of all Web pages.









Learn tab includes pages for the

Standards tab includes pages for the Tools tab includes pages for the

following:

following: following:

 Learn Home page

 Standards Home page  Tools Home page

 CDE Project Overview

 General CDEs  CDE Catalog

 How data become CDEs

 Amyotrophic Lateral Sclerosis (ALS)  CRF Library

 Glossary

CDEs*  Form Builder

 Sharing of data

 Congenital Muscular Dystrophy (CMD)

CDEs*  Collaborations

 Epilepsy CDEs  Tutorials (coming soon)

 Friedreich's Ataxia CDEs *

 Frontotemporal Dementia (FTD) CDEs*

 Parkinson’s Disease CDEs

 Spinal Cord Injury (SCI) CDEs

 Stroke CDEs

 Traumatic Brain Injury (TBI) CDEs



*CDEs in development

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Standards pages









The Standards portal is organized by neurological disease/disorder. Each of the Standard pages

includes the following:

 Standardized data element definitions and instructions (CDE Detailed Report) intended to

expedite the development of data collection tools (see Figure1 below)

 Case report form (CRF) Modules/Guidelines (see Figure 1 below)

 A brief overview of how the general/disease-specific standards were developed





 The CDE Standards currently available on the  The additional disease-specific standards

Web site include: shown below are currently in development. The

following CDEs will be added to this Web site as

 General CDEs (applicable to numerous soon as they become available:

diseases and conditions)

 Epilepsy CDEs  Frontotemporal Dementia (FTD) CDEs

 Parkinson's Disease (PD) CDEs  Headache CDEs

 Spinal Cord Injury (SCI) CDEs  Huntington’s Disease (HD) CDEs

 Stroke CDEs  Multiple Sclerosis (MS) CDEs

 Traumatic Brain Injury (TBI) CDEs  Neuromuscular Disease

o Amyotrophic Lateral Sclerosis (ALS)

CDEs

o Congenital Muscular Dystrophy

(CMD) CDEs (public comment under

review)

o Friedreich's Ataxia CDEs

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





[Figure 1] http://www.commondataelements.ninds.nih.gov/General.aspx









Figure 1 Relevant Terminology:

 Domain – categories of data common to clinical research studies that are used to organize

the CDE materials.

 Sub-domain– a lower-level component of a domain, used to further categorize or classify

the CDE materials.

 CRF Module – logical organization of CDEs for data collection. Each module contains a

template case report form (CRF) and instructions for data collection.

 Guideline –an instructional document that provides further details about the CDE materials

or provides justification for why certain elements or standardized instruments/measures

were included in the CDE recommendations. Unlike a CRF Module, the Guideline does not

contain individual CDEs.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





 CDE Detailed Report – contains detailed information about the selected CDEs; including

CDE definition, permissible values/codes, additional instructions, references, etc. Another

name for a CDE Detailed Report is Data Dictionary.



Other information included on the Standards pages are (see figure 2 below):

 Summary of Updates

 History and Acknowledgements about the CDE Working Group

 Online feedback form to submit comments and suggestions

 Additional references



[Figure 2] http://www.commondataelements.ninds.nih.gov/General.aspx

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Tools pages









The Tools portal includes tools that combine the content from the pages of the Standards portal.



 CDE Catalog – browse the universe of all CDEs available to users.

(http://www.commondataelements.ninds.nih.gov/CDE.aspx)

 CRF Library – searchable repository of all CRF Modules and various Guideline

documents that have been created through the NINDS CDE Project.

(http://www.commondataelements.ninds.nih.gov/CRF.aspx)

 Form Builder – assists data managers to create data dictionaries for their

customized study forms.

(http://www.commondataelements.ninds.nih.gov/CRF.aspx?source=formBuilder)





CDE Catalog: this tool allows users to search the full universe to isolate a subset of the CDEs (e.g.,

all stroke-specific CDEs related to imaging, all pediatric epilepsy CDEs, etc.) and download details

about those CDEs.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





CDE Catalog result grid: users can view their CDE search results and are able to generate CDE

Detailed Reports and CDE Snapshot Reports.









CDE Snapshot Report: contains the most important information about the CDE. The CDE Detailed

Report contains additional information not included in this report. Please refer to the CDE Snapshot

Report example on the next page.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)







CDE Detailed report: contains all the detailed information or meta-data about the selected CDEs. Unlike the CDE Snapshot report that

just includes the most important details about a single CDE, the CDE Detailed report includes all CDEs found through the search of the CDE

Catalog tool and includes additional classification information.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)







CRF Library: this tool allows users to search the universe of all CRF modules and guidelines and

find documents of interest.









CRF Library result grid: users can view their search results and choose to view and/or download

the CRF modules/guidelines and their corresponding data dictionaries.









CRF Module and Guideline

document page – Users have access

to the CRF module/guideline and its

data dictionary for viewing and

downloading

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Form Builder: this tool allows users to assemble CDEs to build a data dictionary for a customized

case report form (CRF) or “form”.



The form builder was designed to have the same functions and content of the CRF Library and CDE

Catalog while having additional features to allow users to create their form by customizing existing

collections of CDEs (i.e., CRF Modules).



CRF Library for Form Builder: users can begin building a form by selecting the collection of CDEs

from one or more existing CRF modules.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





CDE Catalog for Form Builder: after having chosen one or more CRF modules from the CRF

Library for Form Builder page, users can add or delete CDEs from their Form Builder cart.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Form Builder Cart: shows the CDEs that have been chosen to build the customized form. Users are

able to download the data dictionary for their customized form when they are finished “shopping”

for CDEs.

Introduction to NINDS Common Data Element (CDE) Web site

(http://www.commondataelements.ninds.nih.gov/)





Learn pages









The Learn portal provides resources that allow you to read and learn more about the NINDS CDE

Project and related efforts. The portal includes:

 An overview of the CDE Project

 Explanation of how data become CDEs

 Glossary of key terms

 Information about NINDS’ requirements to share study data

 Description of other groups (e.g., caBIG) NINDS is collaborating with in its CDE Project



In the near future, this portal will also contain tutorials that provide trainings about the CDEs and

offer instructions on how to navigate the Web site.







Tips for Using the CDEs



 When researching CDEs to incorporate into your study design, we recommend that you first

review the General CDE Standards page

(http://www.commondataelements.ninds.nih.gov/General.aspx) and then visit the disease-

specific page most relevant to your study.

 The General CDEs and the disease-specific CDEs are classified using three different levels: Core,

Supplemental, and Exploratory. The Glossary on the Web site

(http://www.commondataelements.ninds.nih.gov/Glossary.aspx) defines these three terms in

detail. It is important to note that all NINDS-funded studies are strongly encouraged to collect

the Core CDEs.

 If you plan to collect a CDE in your study please use the definition and permissible values/

codes specified for the element. The NINDS CDE Project will not accomplish its goal of

standardization if users continue to use idiosyncratic definitions and permissible values.

 Provide feedback about the CDEs, their supporting documentation and the Web site. The

NINDS CDE Team (NINDSCommonData@kai-research.com) welcomes feedback in any format

you are willing to provide it (e.g., using the online feedback form on the Web site, sending an

email, talking to us over the phone, etc.). Most of the CDEs are only version 1.0 and they will

only continue to improve and become more valuable resources with feedback from the research

community.



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