Frequency and plans for auditing trial conduct {23}
Every effort will be made to comply with the requirements of the trial protocol and the investigator is not allowed to deviate from the protocol. Waivers are prohibited. As required by national regulations or guidelines, requests for deviations and reports of deviations will be provided to the responsible Ethics Committee (EC) if the deviation affects resident’s rights, safety and well-being, or the scientific integrity of the clinical investigation. Under emergency circumstances, deviations from the protocol may proceed without prior approval by the sponsor and favourable opinion of the EC if the rights, safety and well-being of human residents need to be protected. Such deviations will be documented and reported to the sponsor and EC as soon as possible in accordance with national regulations. Regular trial monitoring visits will be performed by the clinical trial audit departments of the University Trial Centres.Should a monitor or the sponsor identify non-compliance, this will be notified to the investigator in writing, with a request to correct the source of the deviation immediately. Corrective action will be implemented to avoid repeated non-compliance, which will usually include re-training and may include terminating the clinical investigation at the site. The sponsor is responsible for analysing deviations and assessing their significance. Corrective action(s) will be implemented to avoid repeated deviations, which may include suspending the clinical investigation at the investigation site or disqualification of the investigator. Major protocol deviations shall be reported immediately to the sponsor. Minor protocol deviations will be collected by the monitor during the monitoring visits. In case of any major protocol deviations, the designated monitors of the study will be informed by the investigator immediately upon detection.