CT: Data Management Systems for Sponsors of Clinical Trials

This course is designed to assist clinical trials sponsors to design data capture methods, and to organize and manage clinical trial data collected from one or more investigative sites. Topics include data flow from site to sponsor; case report form (CRF) design, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database procedures; patient confidentiality; and ICH Guidelines (21 CFR part 11).