Data management
Data collection is the responsibility of research team members at participating sites under the supervision of the local site investigator who is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data reported. The EDC has created paper and electronic data collection forms for utilization and a detailed Manual of Operations (MOO) that describes source documents, instructions for completing the case report forms, and relevant data handing and monitoring procedures.Research data will be entered into the study’s REDCap database which is password protected and includes internal quality checks built to identify data that are inconsistent, incomplete, or inaccurate. A risk-based monitoring plan details the data monitoring strategy and procedures. All statistical analyses will be coded and conducted independently by two statisticians.