The BTO, housed in the Center for Biobehavioral Health, is a point of entry service for social and behavioral clinical trials at Nationwide Children's Hospital, and a conduit through which investigators streamline connections to resources throughout the Abigail Wexner Research Institute (e.g., Clinical Research Services, Office of Technology-Commercialization). Certified Clinical Research Professionals, clinical staff including nurses and nurse practitioners, and biostatisticians in the BTO work with investigators to support efficient coordination of services necessary to initiate, implement, and disseminate clinical trials according to Good Clinical Practice and federal, state, and institutional regulations and guidelines.
Services we provide for social and behavioral trials include:
Data Services such as power calculations; study design and analysis consultation; randomization; interim and final analyses; database design, creation, and oversight; data reliability checks and cleaning.
Regulatory Services such as protocol support and development, IRB preparation, submission, and oversight; assistance creating and maintaining the study regulatory binder and manual of procedures; guidance with meeting clinicaltrials.gov registration and reporting requirements; study monitoring services; coordinating research and data agreements.
Clinical Safety Services such as clinical protocol development; adverse event plan development, as well as adverse event collection, assessment, and reporting; liaising with clinical departments; inclusion and exclusion criteria assessment; medical chart abstraction; medication administration; biospecimen sample collection and storage; interpretation of clinical labs.
Study Implementation Services such as participant scheduling; informed consent; data collection; intervention implementation; participant payment; OnCore management.
In addition to the above services, the BTO provides clinical research education, training, and onboarding for staff engaged in social and behavioral clinical trials. The coordination of these supports in a centralized resource increases the pace, rigor, and translation of social and behavioral clinical trials by efficiently supporting all aspects of complex single- and multi-site trials including training, compliance, design, implementation, monitoring, and dissemination.
The BTO maintains a repository of documents and NIH templates to support clinical trial grant development/submission and regulatory aspects of clinical trial oversight. To utilize these templates, contact BTO@NationwideChildrens.org or visit the internal Sharepoint site here: https://nationwidechildrens.sharepoint.com/sites/R10114/SitePages/Home.aspx
Meet Our Team
Joseph Rausch, PhD
Dr. Joseph Rausch received his PhD in Quantitative Methods from the University of Notre Dame. Dr. Rausch is a quantitative methodologist and Principal Investigator within the Center for Biobehavioral Health and a Research Associate Professor of Pediatrics at The Ohio State University College of Medicine. His primary research focus is the analysis of longitudinal data within randomized clinical trials and prospective research studies. Prior to joining Nationwide Children's Hospital in 2015, Dr. Rausch was faculty at the University of Minnesota and the University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center. Dr. Rausch has served as a methodologist on over 80 peer-reviewed publications and more than 20 federally funded projects in the field of pediatrics, including providing mentorship on several NIH research career development awards and serving as the primary biostatistician on randomized clinical trials.
Kelly M. Boone, MA, CCRP
Kelly Boone received her MA in Developmental Psychology from the University of Kansas and obtained her Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates. Kelly brings more than 10 years of experience managing behavioral trials, both in CBH and internationally. Prior to this position, Kelly was the Associate Director for Research at OSU's Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy. There she provided the day-to-day leadership of the organization, with the goal of advancing their shared mission of improving children's learning and development at home, in school, and in the community. Kelly also served as a research coordinator for many years. She managed studies examining DHA supplementation in toddlers born preterm and coordinated a multi-component school readiness intervention for children aged 0-5 years living in designated disadvantaged areas of Dublin, Ireland.
Shivika Udaipuria, MPH
Shivika Udaipuria graduated from dental school in India in 2016 and trained in biostatistical and epidemiological methods at Emory University where she graduated with a MPH in 2019. For past three years Shivika has been working in various research settings. She worked as a clinical research assistant and Emory University and at the Georgia Center for Cancer Statistics before joining Nationwide Children's Hospital as a biostatistician. At the BTO, Shivika has been involved with several clinical studies and has assisted researchers with creating randomization schemes, cleaning and analyzing data. She has also been involved with multiple internally funded projects where she was the primary biostatistician.