The document discusses the Common Data Elements project which aims to standardize data collection in traumatic brain injury (TBI) research. It describes why standardization is important for increasing study power and enabling data pooling across studies. An example is given of the International Mission on Prognosis and Clinical Trial Design in TBI study which established prognostic standards and improved trial design using standardized data. Working groups developed proposals for standardized elements in domains like demographics, biomarkers, imaging and outcomes. The goal is to facilitate high-quality comparative effectiveness research and clinical trials through consistent, electronic data collection.

1. The Common data elements project Standardization of data collection in TBI NNS 2011 Fort Lauderdale, Florida July 11-13, 2011 Andrew Maas On behalf of the WG demographics and clinical assessments Brain Injury TODAY The common data elements project

10. Outcome: recommendations for instruments Domain Instruments Global GOSE Neuropsych RAVLT, TMT, Processing speed Psych BSI-18 Symptoms RPQ Disability FIM: cognitive and motor subscales Social participation CHART-SF Qol SWLS

12. Members WG demographics & clinical assessment David Adelson Phoenix, USA Tom Balkin Washington DC, USA Ross Bullock Miami, USA Doortje Engel Heidelberg, Germany Wayne Gordon New York, USA Cynthia Harrison-Felix Englewood, US Jean Langlois-Orman Houston, USA Henry L. Lew Richmond, USA Andrew Maas Antwerp, Belgium David Menon Cambridge, UK Claudia Robertson Houston, USA Karen Schwab Washington DC, USA Nancy Temkin Seattle, USA Alex Valadka Austin, USA Mieke Verfaillie Boston, USA Mark Wainwright Chicago, USA David Wright Atlanta, USA

17. Elements and templates

18. Example of data elements for TIL Therapy intensity level (TIL): Basic

19. Therapy intensity level (TIL): Intermediate

21. Example of template: age

22. Building a CRF for an acute phase study in severe TBI

23. CDE’s published