Site Quality Management Tools: Writing Effective SOPs
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); and 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; and Guidance for Organizing Effective Training Sessions.
Upon completion of this training program, participants should be able to:
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.
This course helps site personnel involved in quality management systems build competency in Clinical Trials Operations (GCPs), Communication and Teamwork, Ethical and Participant Safety Considerations, Leadership and Professionalism, and Study and Site Management. Explore Competencies >