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Source Data Verification in the Age of AI

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 accross 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 perpective. For example: What is source when the orignial records/transcripts are not maintained? What is the role of investigators in ensuring accurate, artifically created notes and care plans? Does the institution have plans in place to ensure data integity in the age of AI-generated notes?

CEU: 1.00 ACRP

Speaker:

Earlier Event: April 27
Better (Not) Call FDA: When and How to Flag Regulatory Oversight in Your Study
Later Event: April 27
There's a Better Way to Approach Training for New Clinical Trials Team Members