Sponsored by The Northwestern University's Feinberg School of Medicine and the Northwestern University Clinical and Translational Sciences (NUCATS) Institute in collaboration with the Association of Clinical Research Professionals (ACRP). Kit Howard has been in clinical research and development for over 20 years, and has experience in many aspects of basic research, pre-clinical research, and Phase I through IV drug development. She is the founder and owner of Kestrel Consultants, a company that specializes in the development of cross-functional clinical research data and process standards that span protocol definitions through clinical study reports. She is also an instructor for NCCR’s “Pathways in Clinical Research” program. Kit has an MS from University of Michigan’s School of Public Health in Clinical Research Design and Statistical Analysis, and is a Certified Clinical Data Manager. How Clean is Clean Enough? Risk-Based Data Quality in Clinical Trials presented by Kit Howard, MS, Principal and Founder, Kestrel Consultants, Inc.
Tremendous energy is devoted to ensuring data quality, but few organizations have defined what this means. Individual data points are checked but little is done to identify systemic patterns of errors, which are a much greater threat to study validity. This talk will present a risk-based approach for ensuring that clinical data are “clean enough”.
1. Define data quality in clinical trials, and what “clean enough” means
2. Learn techniques for identifying potential quality issues in both individual data points and in aggregate data
3. Understand how to apply quality checks appropriately to obtain data that are “clean enough”
For more information on this event to to be included on our mailing list for future activities, please email us at nucats-ed@northwestern.edu. For questions during the conference on Friday, May 16, 2008, please call 312-926-2383.
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