1. Common Data Elements: Data Standards for Clinical Data Collection
Larry J. Feldman
College Park Scholars – Science & Global Change Program
Bioengineering
College Park Scholars Academic Showcase, May 4, 2016
Introduction
The National Institute of Neurological Disorders and Stroke (NINDS) is the leading source of funding in the United States for clinical research of neurological conditions. To harmonize data collection and use, the NINDS Office of Clinical Research has led an effort to develop Common Data Elements (CDEs) for use in clinical studies in neuroscience. The purpose of the CDE Project is to standardize the collection of investigational data in order to facilitate comparison of results across studies and more effectively aggregate information into significant metadata results.
Activities
Supported the Sports-Related Concussion (SRC) and Traumatic Brain Injury (TBI) working groups develop and standardize CDEs, Case Report Forms (CRFs), and Notice of Copyright (NOC) forms for posting on the NINDS CDE Website. Created and validated CDEs, CRFs, and NOCs and entered into a proprietary Access ‘Interface’ database. Developed and quality checked for multiple neurological instruments (e.g., SCAT3, TOMM) and searched biomedical literature on PubMed to support TBI, SRC-specific research.
CDE Detail
Case Report Form
Notice of Copyright
Site Information:
Emmes Corporation, 401 N. Washington Street, Suite 700, Rockville, MD 20850
Supervisor: Joy Esterlitz, MS
The Site mission: Emmes means truth in Hebrew, and Emmes’ mission is to search for truth in public health issues.
Future Work Develop a process to computer generate NOC data on demand
Discussion
During my time at Emmes, I was able to contribute to many diseases that NINDS was focusing on. My main tasks as an intern was to search the Access interface for existing forms, add existing CDEs and create new ones, and create new forms. It helped me prepare for my future of having to code and handle data in a quick and sufficient manner.
Acknowledgments
I would like to acknowledge my site supervisors Joy Esterlitz, Sherita Alai, and the Emmes NINDS CDE Team.