WELCOME TO THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS), NATIONAL INSTITUTES OF HEALTH (NIH), COMMON DATA ELEMENT (CDE) WEB SITE
|NINDS CDE Updates|
|The TBI CDE recommendations are now available on this Web site. The TBI CDEs were developed through a scientific initiative jointly sponsored by the NINDS, the Department of Veterans Affairs (VA), the National Institute on Disability and Rehabilitation Research (NIDRR), the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (DCoE), and Defense and Veterans Brain Injury Center (DVBIC).|
|The NINDS CDE Web site contains neurology data standards and tools that are intended to help investigators and study staff to collect data with a “universal language” in their clinical studies. These CDE recommendations are currently available on this site:|
|General (Data relevant across diseases)||Spinal Cord Injury (SCI)|
|The Project is also developing CDEs for several other disease areas. These CDEs will be added to this site later this year (listed in the order they will be published):|
|Traumatic Brain Injury (TBI)||Parkinson’s Diseases (PD)||Huntington’s Disease (HD)|
|Epilepsy||Congenital Muscular Dystrophy (CMD)|
|Stroke||Frontotemporal Dementia (FTD)|
|As CDEs for additional disease areas are developed they will be added to this Web site.|
|The NINDS CDE Web site includes several portals (see menu on left):|
|Standards - Start here to find the CDEs you can incorporate into your study. This portal is designed to help investigators and coordinators.|
|Tools - More experienced users can use these tools to help assemble their data collection materials. This portal is designed to provide additional resources to those individuals with data management and/or database expertise.|
|Data Archiving - Provides information about NINDS’ data archiving activities.|
|Databases - Eventually will provide information and links about databases/repositories that include the NINDS CDEs.|
|The NINDS embarked upon and continues to support its CDE Project for a variety of important reasons. To learn more about the Project and its anticipated benefits, please visit the Project Overview. Notably, the CDEs have provided the NINDS an opportunity to work with other NIH Institutes, the Department of Health and Human Services (HHS), federal agencies, not for profit organizations, foundations, and national/international organizations, as well as the scientific community. To date the NINDS has worked collaboratively in the development and distribution of the CDEs by:|
|Expediting the release of standard in the NINDS CDE format - for example, taking the American Spinal Injury Association (ASIA) and International Spinal Cord Society (ISCOS) standards and data sets for spinal cord injury and incorporating them into the CDEs.|
|Reviewing and utilizing existing standards where possible - for instance, incorporating the American Heart Association’s / American Stroke Association’s “Get With The Guidelines” data elements into the stroke CDEs; using the NIH PhenX Toolkit for epidemiological elements.|
|Avoiding duplicate efforts - for example, collaborating with the existing traumatic brain injury standards development by the Department of Defense (DOD), Veteran’s Affairs (VA), and the National Center for Research Resources (NCRR).|
|Harmonizing with other standardization projects - for instance, initiating discussions about adding the NINDS CDEs to existing data standard libraries like the Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute’s cancer Biomedical Informatics Grid (caBIG).|
Common Data Elements
The Common Data Elements (CDEs) have been compiled in a standard format, called the CDEs Data Dictionary (DD). The DD can be utilized by investigators, study coordinators and data managers for data collection and management purposes, as the DD provides data element definitions, response categories, and item labels, as well as other variable components. The CDEs forms provide a sample template of how the elements can be represented on study forms.
The common forms represent case report forms (CRFs) frequently associated with conducting clinical studies across the NINDS disease areas. The common forms have been designed to incorporate the data structure associated with the Common Data Elements (CDEs). The forms are templates for data collection, and Principal Investigators are encouraged to customize the CRFs in order to incorporate study specific data fields.
The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers to expedite the translation of research results into knowledge, products and procedures to improve human health. (See NIH Statement on Data Sharing)
In order to ensure the proper storage and availability of completed National Institute of Neurological Disorders and Stroke (NINDS) studies, the NINDS supports several data archiving activities. As studies are completed and their data become available, this site will aid investigators by providing guidance on which materials to retain for data sharing purposes.
Guidelines and Standard Procedures
Includes information on the Common Data Elements (CDEs) processes, as well as NINDS CDEs guidelines
Sign up here to receive email notifications about Common Data Elements (CDEs) data releases and other CDEs information.
This tutorial was designed to guide users through the basic sections of the NINDS Common Data Elements (CDEs) Web site. It points out various Web site features and provides examples that will help users access and utilize the CDEs materials.