Welsh Government

Monitoring

Facilitator: PharmaSchool

Course Outline:

Under both EU and UK legislation the Sponsor is responsible for the management and conduct of clinical trials and other types of research. This includes the role of the monitor as the primary communication link between the sponsor and the investigational site. This one day course outlines the specific responsibilities of the monitor and offers practical advice on how to perform this role, with specific emphasis on risk adapted monitoring, subject protection and data quality.

The format of the day will include presentations, group work and discussion.

Please note a certificate of attendance will only be issued if delegates complete all elements of the training.


Following the training, participants will be able to:

  • Outline the responsibilities of the monitor
  • Describe the potential risks for a clinical trial
  • Put together a plan for a monitoring visit
  • Identify the priorities for monitoring at site or during centralised monitoring activities

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