2.9.5. Data management and monitoring.
ADVERSE EVENT
No interim analyses will be performed for this phase 3 study. An Independent Data Monitoring Committee will not be established. A Data and Safety Monitoring Board will be established for the purpose of third-party evaluation of safety throughout the study period. All patient data relating to the study will be recorded on electronic case report forms (eCRFs) unless electronically transferred to the sponsor or designee (e.g., laboratory data, electronic patient-reported outcomes). After the follow-up period is complete, all data in the eCRFs for each patient will be locked. Source data verification will be performed to confirm that the data entered into the eCRFs by authorized site personnel are accurate, complete, and verifiable from source documents, that the safety and rights of patients are being protected, and that the study is being conducted in accordance with the currently approved protocol and any other study agreements and applicable regulatory requirements.All AEs and serious adverse event (SAEs) will be monitored from the time of providing informed consent/assent until the end of the follow-up period, as per the schedule of activities (Table 