Learning objectives:

• How AI is being used to facilitate  clinical trial operations today 
• Potential competitive, privacy, regulatory and other risks for sites and sponsors stemming from the other contracting party’s and their vendors’ use of AI, particularly unknown or undisclosed AI usage 
• How contracts are responding to govern these risks
• A careful look at sample AI clauses in contracts - including “no AI” clauses - and how to deal with them
• When should participant informed consent be obtained regarding AI usage and is that consent actually informed 
• A discussion of data sharing clauses, de-identification and secondary use in the Age of AI