The Association of Clinical Research Professionals

Site Quality Management Tools: SOPs, Metrics and Training

IMPORTANT: This training program will not be available for purchase between December 1, 2019 and January 6, 2020 while we transition to an improved training platform. If you purchase this program prior to December 1, 2019, you must complete the course evaluation before December 31, 2019 to receive ACRP contact hours.

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

Master quality-related processes and procedures required to ensure trial compliance.

This comprehensive training program is a must for site personnel involved in quality management and improvement. Building on a solid understanding of the key components of quality management systems (root cause and CAPA) and risk-based decision-making, this course prepares you for the next step of setting up a quality management system at a site.

Training topics include:

  • Quality risk mitigation
  • Comprehensive root cause analysis
  • Development and implementation of appropriate corrective and preventive action plans
  • Development and implementation of effective Standard Operating Procedures (SOPs)
  • Development and delivery of training specific to the CRC role

Access the tools necessary to build and measure a quality process for your site, including:

  • Protocol Feasibility Checklist
  • SOP Template
  • Guidance on Putting SOPs into Practice
  • Sample Quality Metrics
  • Guidance for Organizing Effective Training Sessions

Learning Objectives

  • Explain the importance of quality processes in clinical research conduct by providing a framework for the necessary elements and systems that should be implemented by a site to ensure quality
  • Set up a quality process for your site
  • Organize training sessions to ensure quality in clinical research

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 >>

Audience

Site personnel involved in quality management systems