Quality Assurance & Quality Control Activities

What is the difference between Quality Control and Quality Assurance?

Quality Control (QC) is a reactive process that identifies and corrects deviations from the clinical trial protocol and procedures. It involves checking that procedures have been followed and the data collected is accurate and reliable. Monitoring is a QC activity. It is usually performed by a member of the Sponsor team and is therefore not an independent process.

Quality Assurance (QA) is a proactive process.  It involves developing SOPs, training staff, and conducting internal audits and acting upon the findings for quality improvement activities.  It is an independent activity. At Melbourne Children’s campus, clinical trial internal audits are performed through the Clinical Research Internal Audit Program.  For more information see Internal Audit.