Data management and quality assurance

Data will be stored in a secure, password-protected, web-based database which will only be accessible to authorized project staff. Tablet computers used for ACASI interviews will be password protected and will be stored securely at the Foundation for Professional Development (FPD) offices in the study districts. Paper records of participants will be kept in lockable filing cabinets at FPD offices. Paper records, excluding informed consent forms, will only contain PINs. A separate, access-controlled, link log database will be developed and maintained by the data manager. Qualitative data including audio files and password-protected transcripts will be stored on a secure, access-controlled cloud-based database (SharePoint). Double-data entry of laboratory results will be employed when capturing participant data onto RedCap. Automated data quality checks and skip patterns will be built into RedCap and ACASI. Research assistants will conduct onsite data quality checks daily. Scheduled and unscheduled data quality inspections will be carried out by the data quality assurance personnel in order to ensure high data quality standards. The principal investigators, or their designate, will randomly select 10% of all participant files for inspection every 3 months.