The advancement and rapid utilization of artificial intelligence (AI) scribes and other AI assistant tools in the clinical space raise new questions about what constitutes "source" for data in healthcare settings. During this discussion, we will look at AI scribe programs that are currently being used at major hospitals and clinics across the U.S. in order to identify concerns, discuss mitigations, and better understand what should be considered when conducting site qualification visits from a quality management perspective. For example, what is the source when the original records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artificially created notes and care plans? Does the institution have plans in place to ensure data integrity in the age of AI-generated notes?

CEU: 1.00 ACRP

Speaker:

• Michele La Badie, ACRP-CP, ACRP-MDP, ACRP-PM, Clinical Trial Manager, Shoulder Innovations

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Training is an integral piece of the onboarding process for new staff in clinical research, but is often not approached systematically with evidence-based methodology. This session offers a framework for building efficacious and engaging orientation and training programs that emphasize problem-solving and critical thinking. Attendees will gain skills in identifying common areas of improvement in their own institution's programs and learn how to apply teaching theories and skills to improve their curriculum and align with Joint Task Force competencies. The presentation will culminate in reviewing methods of data collection to assess the impact of changes made to a training program.

CEU: 1.00 ACRP

Speaker:

• Aja Macias, Clinical Research Educator, Stanford Cancer Institute

Signature Series Session

Clinical research is undergoing a dynamic transformation—propelled by breakthrough developments, evolving regulations, and fresh approaches to collaboration. In this fast-moving landscape, adaptability and strategic foresight are no longer optional—they’re essential for navigating what’s next.

David Burrow will offer strategic insights on elevating trial quality and minimizing regulatory uncertainty—sharing forward-thinking approaches and practical tools designed to help research professionals thrive in today’s complex and rapidly shifting environment.

Key topics:

• Emerging trends shaping the future of clinical research

• Foundational principles of Quality by Design

• Leveraging the FDA’s CDER Center for Clinical Trial Innovation (C3TI)

• The growing impact of artificial intelligence on trial design and execution

• Actionable strategies for navigating periods of rapid change

Whether you're rethinking trial design, exploring new technologies, or seeking clarity in a changing regulatory landscape, you’ll leave this session equipped to lead with purpose and drive meaningful progress in a field that’s redefining what’s possible.

At the end of this session, attendees will be able to:

• Explain how emerging trends shape the future of clinical research

• Leverage Quality by Design (QbD) to mitigate regulatory uncertainty

• Understand the FDA’s update on the CDER Center for Clinical Trial Innovation (C3TI)

• Identify actionable strategies for clinical research professionals navigating periods of rapid change

• Explain the impact of artificial intelligence on FDA inspections (so far)

CEU: 1.00 ACRP

Speaker:

• David Burrow, PharmD, JD, Director, Office of Scientific Investigations, U.S. Food and Drug Administration

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