| In accordance with ICH-GCP, monitoring is an essential part of clinical trials and serves their quality control. The Clinical Research Associate (CRA) regularly reviews the rights and safety of patients enrolled, the validity of collected data, the conduct in accordance with the protocol and GCP, and the adherence to laws and regulations. After each monitoring visit, the monitor forwards a written report with all essential details to the sponsor. The study side receives a follow-up letter with all pending tasks. The frequency of monitoring is study-specific and defined in the monitoring manual. The different kinds of monitoring include on-site monitoring (at the study site), remote monitoring (review of the eCRF at the CRA’s office), and risk-based monitoring (review of essential critical parameters). Depending on the requirements of the study, one or more suitable ways of monitoring are chosen at the beginning of a study. |
Deutsche Erklärung |
