Data management {19}
PEx
Streamlined data collection instruments and procedures are used to optimize efficiency and minimize the burden on participating sites. All data are entered into an eCRF by trained project staff. The eCRF is accessed via a web-based Clinical Trial Management System (CTMS). An Australian based company, Research Path, have been contracted to supply a web-based CTMS. The CTMS is a secure application comprising a web-based user interface and associated hosted services (backend) such as the web and database servers. All communication between the user’s browser and database servers is encrypted end-to-end. The core hosted servers (web, database, files) are all located in Australia, conform to the International Organisation for Standardisation requirements (ISO 27001), the Health Insurance Portability and Accountability Act (HIPAA), and Service Organisation Control standards (SOC 2), and employ strict infrastructure security policies. Access to all infrastructure systems and services is controlled through strict security controls and two-factor authentication. All users have permissions defined by their user role type as designated by the sponsor.The project manager, or delegate, performs regular and timely validation of data, queries, and corrections. Any common patterns of errors found during quality control checks are fed back to participating sites. Missing data are minimized through regular data monitoring and a clear and comprehensive data dictionary with online data entry including logic checks.As the PEx cohort is intended to be perpetual, data will be retained indefinitely. In the case of closure of the project, the sponsor will retain an identical replica of the platform database for at least 25 years or longer as is required by the approving regulatory authorities.