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Course Details

Course Title

Advanced Monitoring

Course Format

One or two day classroom course with a mix of presentations and workshop sessions

Learning Objectives

The role of the monitor is a very important one and there are a number of difficult issues which monitors may have to face. Following this course participants will be able to:

  • Describe the responsibilities of the monitor in-depth
  • Manage clinical trial sites more effectively
  • Identify issues issues at site which require escalation
Who is it for?

The course is most suitable for monitors with at least 6 months experience, either of monitoring or of managing contract monitors.

Course Content

Review of clinical trial life cycle

Study management:

  • Overview of planning tools
  • Tracking
  • Study start up
  • Risk assessment, KRIs and contingency planning

Problem solving theory

Optimising subject recruitment

Case studies – dealing with difficult issues at site

Audit and inspection

  • In house audit
  • FDA
  • MHRA

Fraud and misconduct

Enquire About This Course
In-House Enquiry
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