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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.

  • 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

Who should attend?

  • Pharmaceutical, biotechnology and medical device industry
  • Freelancers, self-employed
  • Orientated towards the needs of CRAs with, say 2 – 3 years experience in the job who want to acquire
    advanced monitoring skills and/or refresh existing ones
  • Experienced CRAs
  • Contract Research Organizations
  • Study coordinators, interested in monitoring from the sponsor’s perspective
  • Learning objectives

    At the conclusion of this course participants should be able to:

    • Describe the role and responsibilities of the monitor
    • Evaluate source documents and electronic records competently
    • Identify signs that suggest potential misconduct and fraud
    • Manage monitoring risks proactively
    • Apply Root Cause Analysis techniques when uncovering site problems
    • Develop effective Corrective and Preventive Action Plans (CAPA)
    • Assess the success of corrective action through benchmarking