General (For all diseases)

Updated CDEs for sexual orientation and gender identity to be developed.

The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. The development of the first set of General Common Data Elements (CDEs) began in 2006. The General CDEs were not developed by a Working Group like the disease specific CDEs. Rather the NINDS CDE Team developed the General CDEs by first identifying those data elements that were common across neurological diseases and then harmonizing these common data elements with other relevant clinical data standards (refer to the Project Overview for more information). The NINDS CDE Steering Committee initially reviewed and continues to oversee all revisions and additions to the General CDEs.

The Core data elements to be used by an investigator when beginning a research study in all NINDS related studies are listed in the Start-up Resource Listing.

Many of the CDEs will overlap across study types, which allows for comparisons and meta-analysis across studies. Consistency of the data elements and the CDE formats is kept in order to ensure the ability to transfer critical medical information electronically from one center to another. This consistency also allows for continuity across different disease areas. The goals of the NINDS CDE initiative are to increase the efficiency and effectiveness of clinical research studies and clinical treatment, increase data quality, facilitate data sharing, and help educate new clinical investigators.

Organized by domains and subdomains, often used in clinical studies, data standards include:

• CDEs — Classified as Core, Supplemental - Highly Recommended, Supplemental, or Exploratory
• CRF Modules — logically organize CDEs for data collection
• Guidelines — to provide further information about the CDEs.
• Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

There are file links for the CRF module or Notice of Copyright that will allow you to view and/or download the form. The corresponding CDE Details link will direct you to a separate page to download the specific CDEs related to that CRF module or instrument. Please note that not all instruments have CDE details available, due to copyright restrictions.

The outline that follows includes all the CDEs associated with the CRF modules, organized by domain and subdomain.

Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.