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Advanced GCP Study Monitoring

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Overview 

Clinical Research Monitors perform a critical role in the conduct of a clinical trial. As the primary liaison
between the sponsor and the site, the monitor must verify that the clinical trial is conducted according
to Good Clinical Practice, the safety and rights of subjects are protected, the Investigational Medicinal
Product is handled correctly and the data is of the highest quality. This course will expand and
strengthen the monitoring skills of Clinical Research Associates, enabling them to perform their role
more proficiently and effectively.
Using case studies, monitors will learn how to handle monitoring problems and proactively manage risks
before they become audit findings later. This course includes an invaluable “shared experience session”
which will enable colleagues to discuss monitoring challenges they face.

 

Key Topics

  • Research misconduct
  • Risk Management for the Monitor
  • Elements of Corrective and Preventive Action Plans
  • Advanced Monitoring Techniques and Tools
  • Benchmarking for site performance evaluation
  • Source document/data evaluation
  • Electronic source data verification
Contact your regional office for future dates and locations.
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