Electronic Data Transfer for Clinical Trials

Abstract

The current methods available for the entry of laboratory data into a clinical trial database contain many potential sources of transcription error. Since the results of laboratory tests are usually recorded electronically, if data are transferred electronically, with minimal reformatting, from the central laboratory database to the clinical trial database, potential transcription errors are almost eliminated and there is a great improvement in data entry time. Close liaison between the laboratory and the pharmaceutical company is essential at an early stage. Also, the clinical trial will need to be planned to ensure that case report form and database design are consistent with electronically transferred data. There are numerous advantages and only minimal disadvantages to this method of entering data over the conventional methods.