Inspection Readiness Begins with the Trial Master File (TMF)
The (TMF) is held by the sponsor and represents the story of the study of the study. The Investigator Site File (ISF) is held by the site and represents the story of the study at the site. These documents are the cornerstone of inspection readiness, and it is essential that both the sponsor and site organizations employ strategies for insuring that their TMF/ISF are prepared for a potential health authority inspection from the beginning of every study. This becomes even more critical as many European agencies conduct routine inspections during an active study. Organizations can not only ensure that the documentation is available and complete, but the documentation must tell the story of a study that was conducted to the protocol using principles of Good Clinical Practice (GCP). Ensuring that your ISF and TMF are built in a way that the complete documentation tells the story of the study, will ensure that you are ready come inspection day.