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04-Mar-2020 - 04-Mar-2020

J7 Clinical Trial Administration - Beyond the Basics

  • Location:
    • Cedar Court
    • White Waltham
    • Maidenhead
    • SL6 3LW
    • England
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The Course

Clinical Trial Administrators are at the heart of any project team and play an essential role in the clinical trial process. This course gives an in-depth look into some of the aspects of clinical trials. It aims to give an understanding of the history and evolution of clinical research.Delegates will be guided through the essential documents required at each stage of the clinical trial process and their respective functions, an outline of the key roles and functions, and explores how the role of the CTA fits into the clinical trial process.The course also gives further insight into the EU legislation governing trials, ethics committees, audits and inspections, using and creating SOPs, auditing and archiving. The course will utilise trainer input, exercises, and delegate interaction.

Learning Objectives

• Summarise the impact of the EU Directives on clinical research working practices • Outline the ethics committee submission process • Describe the function of SOPs and outline the process for creating one •Identify essential documents and their respective functions • Describe the key issues in preparing for and participating in an audit/regulatory inspection

Course Outline

• Review of ICH GCP • EU Clinical Trials Directive & UK Legislation  • The EU Data Protection Act  • Ethics Committees & Submissions • Standard Operating Procedures - Their management & writing them • The wider role of the CTA • CTA Key customers & interactions • Essential Documents • Regulatory aspects of Archiving • Key Documents & Version Control • Tracking systems • Data management, data flow & audit trails • Audits & Inspections