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Simulation Comes of Age: AI's Game-Changing Role in Clinical Research Training

As the International Council for Harmonization (ICH) E6(R3) guideline for Good Clinical Practice redefines clinical research through Quality by Design and risk-based approaches, traditional research staff training models must evolve to prepare a workforce capable of applying these principles in real-world settings. This requires innovative, practice-driven training that aligns with regulatory expectations. Thus, this panel explores how artificial intelligence (AI)-enabled simulation enhances onboarding, continuing education, and academic preparation by bridging theory and real-world application while reinforcing key principles outlined in ICH E6(R3).

Panelists will share practical methods for designing and implementing immersive simulations in both in-person and virtual environments targeting such areas as informed consent, medical history assessment, and culturally responsive communication.

Attendees will gain actionable strategies to create engaging learning experiences that integrate feedback, reflection, and structured debriefing to strengthen critical thinking, confidence, regulatory readiness, and participant-centered practices to modernize training. 

CEU: 1.0 ACRP

Speakers:

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The Positive Impact of Digital Protocols on Research Sites

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Rethinking Site Metrics and Turning Them into Actionable Signals