The Association of Clinical Research Professionals

GCP for the Experienced CRA: Improving Monitoring Efficiency and Effectiveness


Member: $189 | Non-Member: $239

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This course is approved for 1.5 ACRP contact hours. Accreditation Details

This eLearning course will be accessible for up to one year from the date of purchase.

Course Description

Test and improve your monitoring knowledge and skills by tackling real-world scenarios and challenges.

Take your knowledge and application of ICH E6(R2) GCP to the next level. Increase your value as a monitor with this advanced GCP eLearning course, which effectively breaks GCP into the following four categories to enable recall, application and efficient monitoring practices in real-world challenges:

  • Verify
  • Ensure
  • Determine
  • Communicate

Monitors and their employers use this training to:

  • Ensure a solid foundation of knowledge of the ICH E6(R2) GCP Guideline
  • Fulfill employer requirements for GCP training
  • Apply appropriate preventive and/or corrective actions following a monitoring-related audit or inspection findings
  • Prepare for an ACRP Certification Exam

Learning Objectives

  • Conduct monitoring to ensure subjects are protected, trial data is accurate, complete and verifiable, and in compliance
  • Describe the selection and qualification criteria for monitors, and the extent and nature of monitoring
  • Document the trial according to section 5.18.4 of ICH E6(R2)
  • Write a monitoring report per section 5.18.6 of ICH E6(R2)

Competency Domains

This course builds competence in the following domains:

  • Clinical Trials Operations (GCPs)
  • Communication and Teamwork
  • Ethical and Participant Safety Considerations
  • Leadership and Professionalism

Learn About Competency Domains for Clinical Research Professionals >>

Target Audience

Clinical Research Professionals involved in monitoring or monitoring oversight