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Course Details

Course Title

Introduction to 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.  This course will provide delegates with the following:

  • Outline of the key responsibilities of the monitor
  • Overview of the tasks a monitor does
  • Practice in some of the more important monitoring tasks
Who is it for?

The course is most suitable for those new to the monitoring role or those looking to progress to a monitoring role in the near future.

Course Content

Responsibilities of the monitor under GCP

The Role of the Monitor

  • Centralised vs On-Site Monitoring
  • Site Selection
  • Site Initiation
  • Monitoring
  • Site Closeout

The Monitoring Plan

  • Risk Assessment
  • Monitoring Plan
  • Key Risk Indicators
  • Risk Mitigation and Management

Essential Monitoring Skills

  • Subject recruitment
  • CRF review
  • SDV
  • Drug Accountability

Other aspects of site management

  • Time management at site
  • Report and letter writing
  • Audit and Inspection

 

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