The Behavioral Trials Office (BTO) is a point-of-entry service for social and behavioral research at Nationwide Children’s. Certified Clinical Research Professionals in the BTO, including Project Managers, Research Coordinators, and Biostatisticians support the efficient coordination of social and behavioral research activities, according to Good Clinical Practice (GCP) and federal, state, and institutional regulations.
The BTO supports numerous intervention and observation-based research projects diverse in clinical area (i.e., otolaryngology, psychology), funding source (i.e., internal, external, federal), and the number of sites (i.e., multi- and single-site).
The BTO provides the following study start-up, implementation, and close-out services:
- Analysis Plan
- ClinCard Setup
- ClinicalTrials.gov Registration
- Coordinate Agreements
- CRF Creation
- ICF Development
- IRB Submission and Communication
- Marketing Materials
- Power Calculation
- Protocol Development
- Randomization Scheme
- Recruitment Script
- REDCap/ Tracking Database Development
- Regulatory Binder
- Biospecimen Storage and Safety
- ClinCard Distribution
- Clinicaltrials.gov Maintenance
- Data Collection
- Data Management
- DSMB Coordination
- EPIC Chart Abstraction
- EPIC Data Request
- Inclusion/Exclusion Assessment
- Intervention Delivery
- Regulatory Binder Management
- Abstract Preparation
- Analyses (Interim/Final)
- Data Cleaning
- Data Management
- Data Reliability Check
- Manuscript Preparation
- Study Closeout
Additionally, the BTO provides clinical research education and training for social and behavioral clinical research staff. Collectively, these supports aim to increase the pace, rigor, and translation of social and behavioral clinical research by efficiently supporting all aspects of complex single- and multi-site trials in training, compliance, design, implementation, monitoring, and dissemination.
Internal NCH users may view the BTOs internal sharepoint for additional information: Behavioral Trials Office - Home (sharepoint.com)
Meet Our Leadership
The BTO team collaborates with research teams to provide the highest standard of services for social and behavioral trials. The research professionals’ skills in project management, methodology, biostatistics and study coordination allow them to support the viability of complex single and multi-site clinical trials.
Dr. Sarah Keim received her Ph.D. from the University of North Carolina. Dr. Keim is a Principal Investigator in the Center for Biobehavioral Health and a Professor of Pediatrics in The Ohio State University College of Medicine and of Epidemiology in the College of Public Health. In the Keim Lab, Dr. Keim's primary research covers early influences on child development, behavior, and growth. She aims to conduct research that improves the health and well-being of children and their families. Outside of the Keim lab, Dr. Keim is the Director of the BTO. As Director, Dr. Keim works diligently with the BTO's Senior Project Manager, Kelly Boone, to grow the BTO's services in strategic and innovative ways. Markedly, Dr. Keim's impact spans academia, policy, and public health. She is a mentor, Post-Doc Fellowship program director, and Associate Editor for the Paediatric and Perinatal Epidemiology Journal.
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. Dr. Rausch works closely with BTO staff and investigators to support the biostatistics services offered by the BTO. Notably, Dr. Rausch has served as a methodologist, primary biostatistician, and mentor on over 80 peer-reviewed publications and more than 20 federally funded projects in the field of pediatrics.
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 to the BTO, over 20 years of social and behavioral clinical research experience, and expertise in clinical research operations. She manages the day-to-day activities and overall BTO portfolio. Kelly is the primary point of contact for the office and works directly with faculty and staff to facilitate their research.