Behavioral Trials Office (BTO)

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:

Study Design and Start-Up
  • Analysis Plan
  • ClinCard Setup
  • ClinicalTrials.gov Registration
  • Coordinate Agreements
  • CRF Creation
  • Design
  • IRB Submission and Communication
  • Marketing Materials
  • Power Calculation
  • Protocol Development
  • Randomization Scheme
  • REDCap Database Development
  • Regulatory Binder
  • SOP(s)
Study Implementation and Oversight
  • ClinCard Distribution
  • ClinicalTrials.gov Maintenance
  • Data Collection
  • Data Management
  • DSMB Coordination
  • Enrollment
  • EPIC Chart Abstraction
  • EPIC Data Request
  • Inclusion/Exclusion Assessment
  • Intervention Delivery
  • OnCore
  • Recruitment
  • Regulatory Binder Management
Study Close-Out and Dissemination
  • 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 Nationwide Children's Hospital 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.


Sarah Keim 

Sarah A. Keim, PhD, received her doctorate 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 Behavioral Trials Office (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.

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Kelly Boone received her master of arts 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 has over 20 years of social and behavioral clinical research experience and expertise in clinical research operations. As the Center for Biobehavioral Health Center Administrator, Kelly works closely with the center director and Abigail Wexner Research Institute Administration to facilitate efficient center operations including fiscal management, training and compliance, space planning and allocation, and the Behavioral Trials Office.>

Nationwide Children's Hospital Staff, Jennifer Filipkowski 

Jennifer (Jen) Filipkowski received her bachelor of science from the University of Dayton and earned her Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates. Jen has a background in education and brings over 10 years of research experience to the Behavioral Trials Office. As project manager, she oversees the day-to-day operations and portfolio of the BTO and serves as the primary contact for the office. Jen also supports and advises clinical research coordinators and monitors compliance, quality assurance, and protection of human subject rights.