The Difference Between Clinical Trial Auditing And Monitoring

While both trial auditing and trial monitoring have the same goal of protecting participant safety and rights, they are two separate yet important pieces of the clinical trial process. Both are conducted by independent reviewers, though the focus is different. Audits are a high level review focused on regulatory compliance and protocol adherence. They are often performed on behalf of an outside entity such as a sponsor, IRB, or government agencies. Monitoring is a continuous process throughout the clinical trial performed on behalf of the principle investigator or sponsor as part of their study oversight. All facets of study conduct are examined with the goal of ensuring high quality data and offering process improvement support.