The new standard is expected to be adopted by all participants of the International Council for Harmonization by June 2017.
According to Svetlana Zavidova, Executive Director, Association of Clinical Trials Organizations (ACTO), the update introduces an important concept of a certified copy and definitions for monitoring plan and computerized system validation. The new amendment also addresses such issues as investigator responsibilities, risk-based approach to quality management, etc.
This is the first revision in 20 years that is justified by rapidly changing technologies and industry development.
“Despite the new additions, the essence of the previous version stays intact. These changes are evolutionary in nature, not revolutionary. They cover new definitions, which are actively used in clinical trials today,” comments Svetlana Zavidova.