Chiari I Malformation

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

• CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
• CRF Modules — Template forms that logically organize CDEs for data collection
• Guidance Documents — Provide further information about the CDEs
• Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)

Chiari I Malformation Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Chiari I Malformation study start-up

Chiari I Malformation Highlight Summary: Overview of all Chiari I Malformation-specific CDE recommendations as they appear on the website

The first set of Common Data Elements (CDEs) for CM1 was developed in partnership with the Bobby Jones Chiari & Syringomyelia Foundation in 2016. The purpose of the Chiari I Malformation Common Data Elements (CDEs) is to facilitate research by providing a standard definition for common, previously used research variables so that they may be used in a more uniform fashion across the available literature. The listing of Common Data Element and Instrument definitions and tools is not intended to limit the consideration of any other variables in the investigation of Chiari I Malformation, but merely to standardize the use of frequently observed variables, where possible. It is recognized, for example, that other metrics, especially those involving the characterization of soft tissue and CSF volume and shape, or those involving dynamic physiological measures, are likely important to future Chiari investigation and perhaps, ultimately, its evaluation and treatment. These metrics have not yet been included in this iteration of the Chiari I Malformation CDEs because there are no current standardization methods available. It is our hope that these elements may be part of future versions of the CDEs to further advance the literature. Finally, we should be mindful that it is not the purpose of these CDEs to define Chiari I Malformation itself or to guide surgical treatment; these CDEs are a tool for research purposes.

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