Data processing pathway {19}
CRF
CRF
Data will be collected at each site by local investigators and sent to the LSHTM CTU Global Health Trials Group. On completion of the paper CRF, data will be submitted by authorised investigators into the trial database held by the LSHTM CTU Global Health Trials Group, accessed via a unique username, password, and PIN. Data will have a one-pass data entry by investigators entering forms directly onto the trial database. One hundred per cent of data received will be subject to automatic electronic validation checks built into the database, such as checks of ranges and illogical values, and manual review, in line with the I’M WOMAN Database Development and Validation Plan and I’M WOMAN Data Management Plan. Missing data will be recorded and presented as such, not imputed. Correction of discordant data will be resolved through queries on the trial database via the inbuilt query management system, followed up regularly until resolved.