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Clinical Trial Start-Up Process

We will review the entire clinical trial study start-up process including some of the processes that are less familiar such as Value Analysis, Non-Indemnification and Material Transfer and Data Use Agreements. This presentation will be useful for those wanting to better understand the clinical trial start-up process.      Presenters:   -Patty Coleman, MBA, CRSO Financial Manager   -Jessica Heskel, CRSO Executive Director

Bridging Research and Real-World Impact: Partnering with Cooperative Extension

This session offers a practical introduction to partnering with Cooperative Extension to conduct community-based and translational research. We will begin with a brief overview of Extension’s mission, structure, and statewide reach, emphasizing how its trusted local networks support rigorous, real‑world inquiry. Using a research project conducted within the 4‑H program as an example, we will illustrate how studies progress from proposal development to on‑the‑ground implementation in Extension settings.

Clinical Research Support Office Annual Update

FY25 CRSO Clinical Research Update including staff, project, and metrics updates as well as a live demo of our recently implemented Advarra eReg electronic regulatory binder system. Presented by:Jessica Heskel, MBACRSO Executive Director   Bibi Broome, MACRSO Research Systems Educator

Forecaster: Accessible Time Series Predictions

Time series forecasting has applications across domains and industries, especially healthcare, but the technical expertise required to implement these methods can be a barrier to using these techniques. We've developed a web platform that makes the process of analyzing and plotting data, training forecasting models, and interpreting and viewing results accessible to researchers and clinicians. This presentation will discuss this platform, giving insight into how it was developed and how it can be used with a variety of data.   Presented by:

Translational Engineering Technology for Women’s Health Applications

Female reproductive and gynecologic health are historically understudied fields that would significantly benefit from engineering expertise due to the unique biomechanical environment in the female reproductive tract and the dynamic tissue changes orchestrated throughout the menstrual cycle by sex hormones. With the synergistic techniques of tissue engineering, biomaterials science, biomechanics, and reproductive biology, we engineer models of the female reproductive system and female lower urinary tract, including the endometrium, decidua, vagina, and bladder.

Advancing a Novel Bloodborne Infection and Drug Supply Surveillance System through a Translational Science Collaboration

Presenters:Hilary L. Surratt, PhDProfessor, Behavioral Science   Kristen McLaurin, PhDAssistant Professor, Pharmaceutical Sciences

Dose Selection Balancing Efficacy and Toxicity Using Bayesian Model Averaging (BMA)

Presenter:A. Lawrence Gould, PhDMERCK & Co.

So, You’ve Built an AI Tool: A Biostatistician’s Guide to Evaluation and Validation of AI-based Tools in Clinical and Translational Research

Presenter:Tony Mangino, PhDAssistant Professor of Biostatistics

ClinicalTrials.gov at UK: Guidelines for Investigators on Clinical Trials Registration and Results Reporting

Session objectives: Review the purpose of ClincalTrials.gov Review which studies need to be registered and discuss how to register your study Describe general requirements and your responsibilities after registration Describe the general requirements for results submission Summarize potential consequences of noncompliance Presented by:Ashley Walton-RobbinsClinical Trials Compliance Administrator