抄録
In the current clinical trials, clinical data which was originally recorded on source data is transcribed into CRF by physicians or CRCs, and CRAs verify source data and CRF. However, transcription and verification are labor-intensive jobs. If the information of source data could be electronically transmitted to CRF, transcription and verification jobs are unnecessary. However, transmission of all necessary data is difficult. Therefore, we carried out surveys for CRCs and CRAs about which data items should be transmitted and what problems might occur. We obtained responses from 370 CRCs and 252 CRAs. It was suggested that data items which can improve efficiency of clinical trials are “Concomitant Medications”, “Medical History/Complications”, “Laboratory Test Results”, “Adverse Event”, and “Vital Signs”. And various problems were listed; in paticular, CRCs were concerned about “Security” and CRAs were concerned about “Reliability and Assurance of the System”.
