Data management {19}
CRF
CRF
All data will be collected on paper based CRFs and safely stored within locked cabinets at the main trial site. Data from the CRFs will be quality checked by the local trial project manager (PM), as soon as possible. Any errors will be resolved with the individual who initially completed the CRF and verified against source documents where possible. All data will then be entered on electronic data collection tools designed on REDCap. The database has inbuilt validations to ensure data entry is as accurate as possible and during database development it went through multiple iterations of testing and feedback before finalisation to ensure smooth data entry operations. Data entered on REDCap will be periodically checked by the PM and against the source CRF to ensure there are no discrepancies. The team from the UK will also conduct regular monitoring visits and randomly check 10% of all the data collected and entered to ensure data quality is maintained. Data management procedures can be found in the ‘Document completion, Transport and Storage SOP’ and ‘Data Entry SOP’ created by each site. This is available upon request.