Work Package 3
DATA MANAGEMENT AND STATISTICS
Database Development | eTMF
OBJECTIVES
To facilitate accurate data collection, monitoring, and analysis.
DESCRIPTION OF WORK TO BE CONDUCTED
The LMU data management team will create and execute Data Management Plan, develop Case Report Forms (CRFs). LMU will work with TECRO research, a South African CRO, to build and maintain study database (eCRF with build in edit-checks), and perform ongoing data cleaning in which they will identify and query data discrepancies for resolution by sites, merge and reconcile external data [eg, lab results] with clinical database. The LMU Stats team will finalize the Statistical Analysis Plan, prepare periodic reports of study data to assist the DSMB during the study assessment process, perform the statistical analysis of the multiple end points, prepare final reports for publication of results in scientific presentations and manuscripts, and summarize data for future meta-analysis projects and also assisting in modelling tasks. Other sites (including clinical and PK) will record and transmit study data.
