| Essential documents are required to proof at any time (even years after completion of the trial) that a study was conducted in accordance with GCP and the protocol as well as the applicable laws. Furthermore, they shall document the integrity and quality of the data collected. ICH GCP chapter 8 lists all essential documents that must be available during or after the conduct of a clinical trial. This chapter also lists those documents which must be filed in the Investigator Site File (ISF), the Trial Master File (TMF) and other files. |
Deutsche Erklärung |
