Frequency and plans for auditing trial conduct {23}
Monitoring for this study is provided by the Clinical Trial Center Tübingen (ZKS Tübingen). The monitoring will be conducted according to ZKS Tübingen internal Standard Operating Procedures (SOPs) and a dedicated monitoring manual for the study. The monitoring timelines include, for all centers, pre‐study visit, initiation visit, regular monitoring visits during the course of the trial as well as a close out visit. Usually, monitoring will end with the last visit after full documentation of the last patient enrolled (close out visit). All investigators agree that the monitors regularly visit the trial site, assure that the monitors will receive appropriate support in their activities and will have access to all trial‐related documents. In addition to the monitoring activities, audits can be conducted by the sponsor or assigned auditors. These audits may include checking the whole course of the study, documentation, trial center, investigators and the monitor. The competent regulatory authorities may also conduct inspections. With their participation in the study, the investigator agrees to support the activities of the auditor/inspector, provide them with direct access to the source documents, study documentation and give them the opportunity to audit/inspect the study site, laboratory facilities, storage of the investigational product, etc.