Carolyn Apperson-Hansen, MStat

Carolyn Apperson-Hansen is the Director of the Research Concierge in the Center for Clinical Investigation for the Clinical and Translational Science Collaboration at Case Western Reserve University. Carolyn provides expertise or support in all phases of clinical and translational sciences in the regulatory and technology areas as well as assists inexperienced investigators to understand research study needs and navigate multi-disciplinary research processes. Prior to joining Case in March 2008, Carolyn led a team of statisticians and statistical programmers at the Cleveland Clinic (CC) who supported clinical scientists on a variety of studies related to causes and clinical practice outcomes related to heart disease. Also, she led the FDA regulatory compliance initiatives in her Department; was a primary resource at CC for training and information related to 21 CFR Part 11 as well as HIPAA Privacy, particularly as it relates to the movement of data and data de-identification; and managed the statistics and clinical data management areas of a clinical trials coordinating center. While at CC, she was a member of the PDA Task Force (an international group) on Computer Validation Modernization and Electronic Information Assurance and was an instructor for Pharmaceutical Training Institute (PTI) teaching two-day short courses in Clinical Data Management, Clinical Statistics for Non-Statisticians, Best Practices in 21 CFR Part 11, and Implementing a Risk-Based Approach to Part 11. Prior to CC, she was on the faculty at the University of Virginia as a project statistician for the NeuroClinical Trials Center. She has over 20 years experience in clinical research and holds a Masters of Statistics degree from the University of Florida located in Gainesville, Florida.