Common Inspection Findings Related to the Investigator Brochure—A Regulatory View from the Medicines Control Agency Good Clinical Practice Inspection Unit

Abstract

European countries are recruiting bodies of Good Clinical Practice (GCP) inspectors to fulfill anticipated legislative requirements. Control of investigator brochures is an important aspect of the GCP quality system employed in clinical research. European inspectors seek to verify compliance with GCP by consideration of the administration and content of investigator brochures. In particular, up-to-date information must be made available to all those whose roles in the clinical research process impinge on the safety of subjects.