Abstract: Electronic data capture (EDC)is a technique for collecting clinical trial data in such a way that they are delivered to the sponsor in electronic form instead of on paper.Web-enabled EDC will become the fundamental mode for clinical trial data capture in the future. Source data of EDC includes paper source data and electronic source data.Source data verification (SDV)of the former one is evaluating the conformity of the data presented in e-CRF with source data.Although electronic source data eliminates need for SDV, strict logic check at the time of data entry and investigating audit trials are needed to confirm the authenticity of the data.EDC may realize cost saving and improvement of efficiency and data quality, as well as addressing some problems in PDC based clinical trial.

Key words: electronic data capture, paper data capture, clinical data management, case report form, e-CRF, electronic source data, paper source data, source data verification