Sport-Related Concussion

Data Standards

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 — 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)

Sport-Related Concussion Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Sport-Related Concussion study start-up

Sport-Related Concussion CDE Highlight Summary: Overview of all Sport-Related Concussion-specific CDE recommendations as they appear on the website

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

In the Form Search below, select a Time Frame for your Sport-Related Concussion study to view the CDEs for those types of studies.

The default setting for Time Frame is ‘Any’ and will return results for all time frames.

Acute Time Frame is time of injury until 72 hours.

Subacute Time Frame is after 72 hours to 3 months.

Persistent/Chronic Time Frame is 3 months and greater post-concussion.

Select Comprehensive if your study falls across the study time frames.

Overview

The first set of CDEs for Sport Related Concussion was developed in 2016-2017.

To develop the Sport-Related Concussion CDEs, the Sport-Related Concussion Working Group divided into subgroups to focus on identifying and defining data elements in the timeframes of:

Acute Subgroup (time of injury until 72 hours)
Subacute Subgroup (after 72 hours to 3 months)
Persistent/Chronic Subgroup (3 months and greater post concussion)

Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.

Roster

The Sport-Related Concussion (SRC) CDE Working Group was comprised of three different subgroups. Chairs were appointed to lead the overall Working Group and the individual subgroups. The Working Group members actively developed the CDEs for their specific subgroups and also had an opportunity to review and comment on the recommendations of the other subgroups. The SRC CDE Working Group was supported by the NINDS CDE Team. The complete SRC CDE Working Group roster and the rosters by subgroup are shown below:

Publications

Broglio SP, Kontos AP, Levin H, Schneider K, Wilde EA, Cantu RC, Feddermann-Demont N, Fuller GW, Gagnon I, Gioia GA, Giza C, Griesbach GS, Leddy JJ, Lipton ML, Mayer AR, McAllister TW, McCrea M, McKenzie LB, Putukian M, Signoretti S, Suskauer SJ, Tamburro R, Turner M, Yeates KO, Zemek R, Ala'i S, Esterlitz J, Gay K, Bellgowan PSF, Joseph K. National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations. J Neurotrauma. 2018;35(23):2776-2783. doi: 10.1089/neu.2018.5643.

Updates

Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.