Data collection and handling
All data required as per the study protocol, including clinical and laboratory data, are documented by the investigator or an authorized member of the study team in the medical record of the patient and in the eCRF. Access to the eCRF is password protected and an audit trail is in place. Any entries are tracked and locked to prevent further editing. The investigator at the clinical site is responsible for ensuring that all sections of the eCRF are completed correctly. Entries are checked for plausibility and consistency via eCRF-inherent edit checks and visually by the monitors where necessary. Implausibility and missing entries are queried and to be clarified with the responsible investigator. All relevant documents and data collected within the study will be archived for at least 10 years after termination of the study.