The Biggest Compliance Risks in AI-Enabled Clinical Trials
- 0:00 Where AI Touches Trials
- 8:00 Risk Starts With Intended Use
- 17:00 Validation Beyond Vendor Demos
Practical shifts you can apply this week
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Identify The Highest Exposure
Identify the AI use cases in clinical trials that create the highest compliance exposure.
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Evaluate Tool Classification
Evaluate whether an AI tool should be treated as a GxP-relevant system or decision support function.
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Compare Risk Across Controls
Compare the compliance risks of model design, data inputs, human oversight, and vendor claims.
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Diagnose Weak Control Gaps
Diagnose weak controls in validation, documentation, monitoring, and change management for AI-enabled workflows.
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Draft A Governance Checklist
Draft a practical escalation and governance checklist for high-risk AI deployments in trials.
What we'll cover
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0:00
Where AI Touches Trials
Common use cases across protocol design, recruitment, site selection, data review, and safety.
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8:00
Risk Starts With Intended Use
How to define what the tool may do, who reviews it, and what happens when it is wrong.
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17:00
Validation Beyond Vendor Demos
What real evidence looks like in your workflow, population, and edge cases.
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29:00
Data Integrity And Provenance
Traceability for inputs, outputs, overrides, lineage, and ALCOA+ implications.
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39:00
Consent, Privacy, And Fairness
Where participant data use, transparency, and subgroup performance create exposure early.
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47:00
Vendors, Contracts, And Change
Due diligence, responsibility splits, version control, and why risk does not vanish in an SLA.
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54:00
Inspection-Ready Governance Moves
A practical checklist for ownership, documentation, escalation, and go or no-go decisions.
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59:00
Recap And Live Q&A
Review the risk checklist, then ask questions you would rather catch now than during an inspection.
Questions people ask before registering
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It is built for working professionals involved in clinical operations, quality, regulatory, data, safety, and digital or innovation programs. If AI is touching a trial process you own or review, it will be relevant.
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No. The session focuses on compliance decisions, governance, and practical risk signals, not model math. If you can read a SOP and ask awkwardly useful questions, you are well prepared.
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Yes, a replay will be available for registered attendees. So if your calendar behaves like a clinical trial timeline, you can still catch the full session later.
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If a certificate is being offered, it will be shared with attendees after the webinar. Check your registration details for the exact process and any attendance requirements.
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No. The webinar is framework-first and uses realistic trial examples to show where compliance risk appears. The goal is to help you assess live or planned AI use cases with clearer judgment.
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Yes, the session uses concrete scenarios such as protocol drafting, site ranking, eConsent updates, and adverse event triage. Each example is tied back to intended use, evidence, and governance.