2nd DIA Clinical Operation & Monitoring Workshop in Japan

IT technology used in site monitoring activity has been progressing every year. Not only the allocation system of the investigational product (e.g. IVRS) and EDC (Electronic Data Capture), which are used by sponsors and in clinical sites, but also the ePRO (Electronic Patient Reported Outcomes) into which patients input data directly are increasingly introduced in clinical studies. Site monitoring activity has been changing along with this progress of IT technology. Moreover, the government is proposing further use of IT technology in the ‘clinical research and clinical trial activation five year plan 2012’ initiative. The efficiency improvement of clinical trials using IT technology is also promoted. The near-futuristic measures, which integrate the patient’s information among the clinical sites and transfer the data in a patient’s medical record into EDC, have already started. In accordance with these changes the new approaches for efficiency improvement of clinical trials at clinical sites have also begun to be taken according to the 5-year plan. In this session we are introducing the progress of IT technology used in site monitoring activity and the approaches. This will be a great opportunity for you to learn and discuss how it will change the field’s future.