Data management {19}
Data will be collected through a comprehensive electronic data capture (EDC) system with digital data entry forms deployed and stored on the broad OpenHDS (Health and Demographic System). Specifically, the study questionnaires will be designed and deployed on the Open Data Kit (ODK) platform running on the open-source Android operating system. Data transfer from mobile devices (tablets) to servers will be executed using ODK-Collect and Mirth. Data validation will take place both at (a) point of entry via restricted and confirmatory steps, and (b) on the server, via aggregate-level quality checks and alerts. Backups of both the raw input data and the processed data will be stored on the main project server as well as at each site. An audit trail/log of all data modifications, both in terms of inputs and edits, will be generated automatically and available to RAs or authorized study team members upon request.Every effort will be made to ensure the protection of participant data. In general terms, this means that no identifying data will be transferred to any server unless both (a) its transfer falls within the scope of the project’s protocol, and (b) it is appropriately encrypted and secure.Paper-based source (e.g., hospital records) will be scanned into the safety database locally and entered into the trials´ databases. Paper-based records will redact all personal identifiers of the participant (e.g.; name of the participant, address or telephone number, hospital file number) and will be stored securely at the site.Clinical data management shall be performed in accordance with applicable ISGlobal standards and data cleaning procedures.While completed eCRFs are reviewed by ISGlobal Clinical Research Associates both remotely and at the study site, omissions or inconsistencies detected by subsequent eCRF review may necessitate clarification or correction of omissions and inconsistencies with documentation and approval by the investigator or an appropriately qualified designee. In all cases, the investigator remains accountable for the study data.The investigator will be provided with a physical data drive (in form of CD-ROM, USB, or HDD) of the final version of the data generated by the project once the database is archived and the study report is complete and approved by all parties. The physical data drive will be compliant with international requirements for data storage and retrieval.