WS04: Implementing Common Data Elements in Clinical 
Research Activities

Chair: Lyn Jakeman, PhD

WS04.01 - Overview of the International SCI Data Sets and CDE Project

   Susan Charlifue, PhD - Craig Hospital

WS04.02 - Development of Common Data Elements for Pediatric SCI Research

   Mary Jane Mulcahey, PhD - Thomas Jefferson University

WS04.03 - Use of SCI Common Data Elements in a Patient Registry

   Vanessa Noonan, PhD - Rick Hansen Institute

Session Description

The ability to compare and share clinical data across populations and time points provides an opportunity and efficient means to promote new scientific discoveries and faster access to treatment interventions.  While the potential benefits of using standard data elements and consensus recommendations are well appreciated, there are challenges to implementation due in part to the heterogeneity of data gathering efforts and definitions and individual investigator needs.  In the spinal cord injury field, standardization efforts began with the development of the International Spinal Cord Injury Data Sets (ISCIDS), and these data sets were recently incorporated and harmonized with Common Data Elements (CDEs) from the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health.   The CDEs include data definitions, case report forms, and guidelines for use in clinical SCI research. The NINDS CDEs have since undergone full review by an oversight committee and a new effort has been completed to develop and integrate CDEs for Pediatric SCI clinical research.  Presenters in this session will describe the development and ongoing work on national and international CDE initiatives, provide information on how the standards have impacted data collection to date, address the barriers to such implementation, and describe the development of a registry incorporating the ISCIDS and CDEs.

Learning Objectives

At the conclusion of this session, attendees will be able to:

1. Describe the International SCI Data Sets project and the relationship to the Common Data Elements project of NINDS
2. Identify barriers to and facilitators of practical implementation of data sets and CDEs in routine clinical practice and research
3. Provide examples of how the data sets have been integrated into national and international registries and databases.  
4. Describe ongoing efforts in data sharing and accessibility for SCI clinical research.