The Association of Clinical Research Professionals

Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA

Pricing With Contact Hours

Member: $22.50 | Nonmember: $149

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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.

Pricing Without Contact Hours

Member: $0 | Nonmember: N/A

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

Course Description

Implement a Quality Management System (QMS) and prevent findings related to patient safety, data quality and regulatory compliance.

With the industry moving away from detecting and fixing problems to preventing them, quality management systems (QMS) play a crucial role. The impact of not implementing or incorrectly using an effective QMS can be substantial and far-reaching, and may include putting human subject integrity and well-being at risk, inaccurate trial data and regulatory non-compliance.

Reduce your risks with this eLearning course. Training topics include:

  • Development and application of Corrective and Preventive Action (CAPA) plans
  • Conduct of Root Cause Analysis (RCA)
  • Development and application of risk management strategies

Learning Objectives

  • List the four components of a quality management system
  • Explain the similarities and differences of quality planning, quality control, quality improvement, and quality assurance
  • Define corrective and preventive actions (CAPA) and root cause analysis (RCA)
  • List the methodologies that support a quality management system during clinical trial conduct
  • List two key factors that enhance the excellence of a quality management system

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
  • Study and Site Management

Learn About Competency Domains for Clinical Research Professionals >>


All clinical research professionals.