• Create easily accessible tools for investigators to collect study data. These tools should be especially helpful to new investigators and others working with limited budgets.• Encourage focused and simplified data collection to reduce burden on investigators and practice-based clinicians to facilitate their participation in clinical research.• Improve data quality while controlling cost by providing uniform data descriptions and tools across NINDS-funded clinical studies.The anticipated benefits of the CDE Project include accelerating study start up and facilitating data sharing and aggregation. The standard definitions, measures, and templates should help researchers more rapidly assemble their data collection materials. When studies which have used the CDEs are complete, less effort should be required to transform the data into a common format for aggregation and to perform meta-analyses, as much of the data are defined the same way.

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This pilot study demonstrates that 2D barcode technology and patient safety-software significantly improves the bedside check of patient and blood product identification in an Australian setting.

Background To reduce study start-up time, increase data sharing, and assist investigators conducting clinical studies, the National Institute of Neurological Disorders and Stroke embarked on an initiative to create common data elements for neuroscience clinical research. The Common Data Element Team developed general common data elements which are commonly collected in clinical studies regardless of therapeutic area, such as demographics. In the present project, we applied such approaches to data collection in Friedreich ataxia, a neurological disorder that involves multiple organ systems. Methods To develop Friedreich’s ataxia common data elements, Friedreich’s ataxia experts formed a working group and subgroups to define elements in: Ataxia and Performance Measures; Biomarkers; Cardiac and Other Clinical Outcomes; and Demographics, Laboratory Tests and Medical History. The basic development process included: Identification of international experts in Friedreich’s ataxia clinical research; Meeting via teleconference to develop a draft of standardized common data elements recommendations; Vetting of recommendations across the subgroups; Dissemination of recommendations to the research community for public comment. Results The full recommendations were published online in September 2011 at http://www.commondataelements.ninds.nih.gov/FA.aspx. The Subgroups’ recommendations are classified as core, supplemental or exploratory. Template case report forms were created for many of the core tests. Conclusions The present set of data elements should ideally lead to decreased initiation time for clinical research studies and greater ability to compare and analyze data across studies. Their incorporation into new and ongoing studies will be assessed in an ongoing fashion to define their utility in Friedreich’s ataxia.

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