Abstract: With the developments of computer and net technology, the superiorities of Electronic Data Capture(EDC) system are increasing in clinical trials and it is getting popularity in trial participants. With the help of the excellent technologies, EDC simplifies the trial process of traditional paper CRFs and overcomes the lags of data entry and data cleaning. The roles and responsibilities of sponsors, monitors and data managers change. Meanwhile, EDC makes it feasible to apply new trial designs and statistical methods, such as, adaptive design.

Key words: Electronic data capture, Case report form, Source document verification, Adaptive design