Data management {19}
Data management will be conducted in accordance with BI’s standard operating procedures and industry standards. BI’s data management process supports International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice. Data will be collected directly via an electronic case report form or external data upload (e.g. for central laboratory results). In accordance with regulatory requirements, the centre trial investigator will prepare and maintain source documents and trial records for each patient, including all observations and other data pertinent to the investigation. Coding will be performed according to the current available dictionaries, with updates twice per year; range checks will be established during database set-up. The Medidata Rave Electronic Data Capture system will be used for database set-up and conduct. The investigator/institution will allow trial-related monitoring, audits, institutional review board (IRB)/independent ethics committee (IEC) review and regulatory inspections. Direct access will be provided to all source documents/data, including progress notes and copies of laboratory and medical test results, which must be available at all times for review by the clinical research associate, auditor and regulatory inspector.All data management procedures are documented in the trial Data Management Plan (DMP), which describes the processes and procedures for the collection, processing and quality control of clinical trial data performed by Data Management throughout the lifecycle of the clinical trial; these processes and procedures are implemented to create and maintain high-quality data collection systems and to ensure data integrity. The DMP serves as a communication and reference tool for clinical trial teams to create and maintain a high-quality database for analysis.