Abstract
In conventional clinical studies, costs of data quality control and the burden of paper case report form collection tend to rise, because of making and filling out a paper case report form based on each clinical study protocol. The secondary use of electronic medical records is expected for cost reduction and quality improvement of clinical studies. The purpose of this study is to develop a data capture system for clinical studies to accumulate necessary information from electronic medical records, and to evaluate the prognosis, prognostic factors, outcomes of treatment and safety of that. In Outpatient Oncology Unit, Kyoto University Hospital, we developed a data capture system which includes a cancer clinical database system and a data warehouse for clinical studies. We are planning to promote the cancer clinical database system in other institutions and collect data to the data warehouse to establish large-scale database for clinical studies of cancer. Cost reduction and quality improvement of clinical studies are expected from this system.