According to Health Industry Insights, 2007 will be the watershed year for industry’s move to broad scale use of electronic data capture (EDC) in clinical trials. The FDA has also recognized the move to EDC with a new guidance on computerized systems used in clinical investigations. This workshop will provide sponsors, CROs, investigational sites, IRB members, and EDC and electronic health records (EHRs) vendors the opportunity to discuss and propose process changes, assessment/audit methods, and delivery practices for assuring the quality of electronically captured data across the whole chain of clinical trial activities.