Data Integrity: The Role of Quality Assurance for Data Integrity

Clinical trial data integrity has traditionally been an integral part of quality assurance. This course describes quality assurance in the light of new data collection methods and procedures. Topics in this course include: Overall Approach to Quality, Quality Activities, and Documentation. After completing this course, learners will be able to identify the role of Quality Assurance in data integrity, and recognize regulatory compliance auditing and QMS auditing.

After this course learners will be able to recognize the definition and importance of a process approach to quality, and recognize activities that help maintain quality of data. identify examples of deviations and nonconformances that must be recorded.