2018 Annual Meeting

Applying Epidemiology Across the Lifespan to Improve Health Care,
Inform Health Policy and Enhance Population Health




Workshop 3

Data Matters: Improving Your Study through Professional Data Management

Location: University of Cincinnati, Medical Sciences Building (MSB), Room E-161

Co-Chairs: Katherine Howard, MS, CCDM, Clinical Data Interchange Standards Consortium (CDISC) and Richard Ittenbach, PhD, Professor, Cincinnati Children’s Hospital and the University of Cincinnati College of Medicine



The purpose of this session will be to describe the science of clinical data management and identify the skill sets and knowledge base needed by today’s clinical data managers. We will identify points in the research life cycle where data management can be most helpful as well as principles for selecting an appropriate data management strategy for your institution.



The purpose of this workshop will be to introduce epidemiologists to the science of clinical data management as both a profession and a developing subspecialty of clinical research.  The workshop will be divided into four discrete parts: (a) description of clinical management and its evolution over the years, (b) knowledge base and skills needed to meet good clinical data management guidelines and practices, (c) points in the lifecycle of a research study in which data management can be most influential, and (d) recommended strategies to help learners optimize data management practices within their own institution.  The workshop will be four hours in length and contain formal presentations as well as small group discussions to enhance learning.

Ball Clinical Trials Article

6-Design and Development of Data Collection Instruments Article


Brief Biographies:

Kit Howard, MS, CCDM has over 30 years of experience in many areas of clinical research, including bench research, pre-clinical research, data management, programming, and developing data and process standards for exploratory through post-marketing clinical trials. She is the Director of Education for CDISC, and serves as co-leader of CDISC’s Medical Device Standards Development team.  She also serves on the CDASH (data capture standard) Leadership team, the Medical Device Controlled Terminology team, and the CDISC Global Governance Group. She has been a member of the Society for Clinical Data Management for 16 years, serves on SCDM’s Academic Task Force, and has been a contributing author and editorial board member of SCDM’s ‘Data Basics.’ She was also one of the early members to earn the SCDM Certified Clinical Data Manager (CCDM) certification.  Kit earned her graduate degree from the University of Michigan’s School of Public Health in Clinical Research Design and Statistical Analysis. 


Richard Ittenbach, PhD, PSTAT is a Professor of Pediatrics, in the Division of Biostatistics and Epidemiology at Cincinnati Children’s Hospital and the University of Cincinnati College of Medicine.  He is a professionally certified statistician through the American Statistical Association (PSTAT) and has been actively involved in clinical data management at the local and national levels for more than 15 years, with a particular interest in training the next generation of clinical data managers. Dr. Ittenbach is actively involved in the Society for Clinical Data Management, its Academic Task Force, and has served as a consultant to academe and industry, as well as a data management content area expert for the U.S. Department of Labor. Areas of research interest include mixed methods study designs as well as the development and refinement of pediatric measures for children with chronic and life-threatening conditions. His articles have appeared in Academic Medicine, American Journal of Bioethics, Journal of Medical Ethics, and Medical Decision Making.

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