Multicenter clinical research studies are complex and costly to implement yet fundamental to addressing the field’s most pressing clinical questions. As clinical research continues to proliferate in the acute injury setting, it is more important than ever to equip researchers and other contributors to adequately address the multiple threats to research validity in both the study design and implementation phases. The foundation of this preparation is non-context specific and relies on the research validity theoretical framework. However, building a study upon the theoretical foundation is a nuanced and setting-driven endeavor. This workshop will give participants an opportunity to review the key concepts of research validity from experts in research methods who are leaders of a coordinating center for a clinical trials consortium. Participants will then engage in a lab exercise guided by experienced injury clinical trialists and will work together in small groups and to apply their understanding of threats to research validity as part of a realistic study implementation exercise. Workshop Agenda --- A. Importance & Relevance of Content - 2 minutes (Didactic); B. Research Validity Key Concepts - 10 minutes (Didactic); C. Study Design Considerations to Minimize Threats to Validity - 15 minutes (Didactic); D. Exercises/Activities (Small group work): 1. Identifying Threats to Research Validity - 10 minutes; 2. Developing a Study Training - 25 minutes; E. Small Group Presentations & Discussion - 25 minutes; F. Handouts: 1. Research Validity Framework; 2. Identifying Threats to Research Validity Lab exercise; 3. Developing a Study Training Lab exercise
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