Stroke

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)

Stroke Start-Up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for stroke study start-up

Stroke Highlight Summary: Overview of all Stroke-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.

 

Overview

The National Institute of Neurological Disorders and Stroke (NINDS) formed the Stroke v1.0 CDE Working Group (WG) in July 2009. Chairs were appointed to lead the overall WG and the nine individual subgroups. The subgroups met regularly by teleconference in 2009 and 2010 to define the Common Data Elements (CDEs) for their domains and to recommend standardized, validated instruments for stroke research. The first set of CDEs for Stroke was completed in 2010.

NINDS formed an Oversight Committee (OC) to periodically review, direct the updating, and advance the development of Stroke CDEs in 2012.

In 2015, the Stroke OC reviewed the Core Stroke CDEs and determined needed classification updates based on disease stage and study type.

Based on the Stroke OC’s input, a Stroke v2.0 CDE Working Group was convened in 2018 to perform a comprehensive review of the Stroke CDEs. The WG was also asked to review the Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage (SAH) CDEs for inclusion and harmonization. The Stroke v2.0 CDE WG was divided into eight domain-specific subgroups:

  • Stroke Presentation and Vital Signs
  • Medical History and Prior Health Status
  • Stroke Types and Subtypes
  • Hospital Course and Acute Therapies
  • Long Term Therapies
  • Outcomes and Endpoints
  • Imaging
  • Biospecimens, Biomarkers, and Laboratory Tests

The Stroke v2.0 CDEs were posted in summer 2020.

The Stroke CDE Working Group and Oversight Committee are supported by the NINDS CDE Team.

Download a “checklist” to help locate the CRF modules that are part of the Data Standards. Each checklist provides an outline of the CRF modules that may be needed for a stroke clinical trial/other type of clinical study.

Checklist for Stroke Clinical Trials
Checklist for Other Stroke Clinical Studies

Roster

Lists members of the Stroke v1.0 CDE Working Group by subgroup, previous members of the Oversight Committee, and the NINDS CDE Team.

Members of the Stroke v2.0 CDE Working Group by subgroup, current members of the Oversight Committee, and the NINDS CDE Team are listed below.

Please see the Overview tab for additional project background and timeline information.

Publications

Publications

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.

Stroke CDEs Revision History