3-day Virtual Seminar

AI for Good Clinical Practice (GCP)

Overview

This webinar connects responsible generative AI use with the principles that underpin modern Good Clinical Practice. It begins with the changing GCP landscape under ICH E6(R3), including its focus on quality, proportionality, critical thinking and technology-enabled trial conduct, before considering what those principles mean when clinical research professionals begin using generative AI.

Participants will look at selected AI-supported activities such as information organisation, summarisation, preparation of internal working content and routine communication. The session then considers the controls surrounding those activities: verifying AI-generated information, protecting confidential and participant information, maintaining reliable records, respecting approved systems and procedures, and ensuring that sponsors, investigators and other responsible professionals retain oversight.

Why you should Attend

Generative AI can make clinical-trial work faster, but convenience can encourage people to use it in situations where the consequences of an inaccurate or poorly controlled output are much greater. Sensitive information may be entered into unsuitable tools, summaries may omit critical detail, and confident AI wording can disguise errors.

With GCP itself evolving to accommodate modern technologies and risk-proportionate trial conduct, clinical research professionals need a practical understanding of how AI fits into that environment. This webinar helps attendees recognise useful applications while keeping quality, participant protection, reliable trial results and professional responsibility at the centre of AI use.

Areas Covered in the Session

• Understand the purpose of GCP and the key direction of ICH E6(R3), including quality by design, proportionality, participant protection and reliable trial results
  
• Consider where generative AI may support lower-risk knowledge, administrative and communication activities within GCP-regulated environments
  
• Explore how AI can assist with organising suitable information, summarisation and preparation of internal working content
  
• Recognise AI limitations such as hallucinations, omissions, outdated information and loss of important clinical or regulatory context
  
• Use human review and reliable source material to verify AI-assisted outputs before they are relied upon
  
• Understand why participant information, confidential data and other sensitive material require careful handling when generative AI tools are used
  
• Consider data governance, record reliability and the importance of working within approved organisational systems and procedures
  
• Distinguish AI productivity support from trial activities requiring clinical judgement, formal oversight, validated processes or specialist expertise
  
• Apply a proportionate approach to AI use based on the task, potential impact and responsibilities held by sponsors, investigators and clinical research teams
  

Who Will Benefit

• Clinical Research Associates (CRAs)
  
• Clinical Trial Managers and Clinical Project Managers
  
• Clinical Research Coordinators and Study Support Professionals
  
• Sponsor Clinical Operations Teams
  
• Investigators and Site Research Professionals
  
• Clinical Quality and Compliance Professionals
  
• Regulatory Affairs Professionals supporting clinical trials
  
• CRO Clinical Research Teams
  
• Managers responsible for AI adoption or digital transformation in clinical research