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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.

• 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