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: