Data Management for the Alecardio project was being carried out by teams from the Data Management departments of Julius Clinical (Zeist, The Netherlands), The George Institute for Global Health (Sydney, Australia) and Julius Center for Health Sciences and Primary Care (Utrecht, The Netherlands). This allowed for global coverage for all activities, as well as flexibility.
The Alecardio Data Management team was involved in the following activities:
- Data management plan development (Outlines the study data flow, as well as applicable sops, work instructions and essential documents.)
- Clinical database design and edit check programming (The inform 4.6 Edc system is used to capture and manage the study data. This system allows site staff to enter their study results into an electronic crf (ecrf) via a secured website.)
- Design of integrations with external databases (Coding, central lab, pharmacovigilance, ivrs and adjudication databases) (implementation of database integrations circumvented the need to enter the same data in multiple databases, allow for secure and automated data transfer between those databases.)
- Data review plan development (A cross-functional data review plan was developed to verify data consistency, patient safety and protocol compliance.)
- Training of site and study staff (Julius Clinical developed and facilitated training for site staff and other study staff who are required to work with the ecrf or ecrf data.)
- Project management/study team participation (We provided a definition of roles and responsibilities, management of the team, coordination of the activities).
- Edc user management (We activated, updated or deactivated accounts based on status in the study, assigned user rights, based on study role and status with regard to ecrf training completion.)
- Data consistency review and query management (By means of predefined manual review on the ecrf data and ad hoc review.)
- Database reconciliations (Ensure that the data matches between all databases that capture those data, regular reconciliations are performed.)
- Report, metrics and data listing development and management (Multiple reports, trackers and data, trends.)
- Data freezing and locking. Data freezing is the process of making data non-editable, which ensures the clean data retains its cleaned state. At the end of the study, after all data were concluded to be accurate, the ecrf was locked, meaning no further additions, changes or deletions can be made to the ecrf. This assures data integrity for statistical analysis.