Monitoring, including Risk Based Monitoring

Monitoring is a very important sponsor responsibility.  We provide training on risk assessment and monitoring plans, monitor responsibilities and the skills needed to monitor to the highest standards.  We pride ourselves on providing interactive elements which test course participants and apply the theory in a practical manner which develops understanding of the requirements and how that translates into the day to day work of a  monitor.

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 it is suitable 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.

Example content:

Responsibilities of the monitor under GCP

The Role of the Monitor

  • Selection visits
  • Initiation visits
  • Monitoring visits
  • Closeout visits

On-site vs Centralised monitoring

  • Pros and cons of each approach
  • Monitoring Plans
  • Key Risk Indicators and Quality Tolerance Limits

Essential Monitoring Skills

  • Subject recruitment
  • CRF review
  • SDV
  • Data Query Resolution
  • IMP Accountability
  • Investigator Site Files
  • Issue Identification, escalation and resolution

Other aspects of site management

  • Communication skills
  • Time management at site
  • Report and letter writing
  • Audit and Inspection preparation

Please contact me for more information and to organise your course.

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