Quality risk management must now be a focus of any clinical quality system for all stakeholders, including investigative sites. Most sites have not incorporated the benefits of a risk-based approach to study conduct. Risk-based approaches have many positive benefits, but getting the clinical operations in order to implement an effective and manageable program can be overwhelming.
This course will present options for implementing a risk-based approach in a site’s quality systems. Examples of site level application and tool development for a risk-based approach from study selection, study management, and performance improvement, to audit readiness for the research site are presented.
Come to this live, interactive 90-minute session and you will be able to:
- Identify the advantages of risk-based study management approaches to quality site performance
- Apply the approaches of quality risk management to site clinical research study conduct
- Develop clinical operations risk-based processes and assessment tools for site study management