817 PROACT: A new way of engaging and empowering patients that fundamentally changes our understanding of tolerability impacts in early clinical development

3. Usability of data structures corresponding to those of the Clinical Data Interchange Standards Consortium (CDISC), who have defined the standard data format to be used in clinical trials. The use of EDC is important in carrying out clinical trials effectively. However, in many cases, EDC cannot be introduced because of the above-mentioned factors. Accordingly, we have created EDC freeware to overcome these concerns. Method: In the proposed system, we provide software that utilizes computer-aided design (CAD). This makes it easy to construct a suitable data input interface by arranging various components on the screen. Furthermore, to enable the use of touch-panel input devices such as iPads or tablet PCs, the resolution and other aspects of the input screen can be adjusted. The tables and database variables of the system conform to the standard domain and variables of CDISC. Results: This system was first used on a server in the local server in 2012, and is currently employed on a cloud server to enable multicenter studies. The system has mainly been used to collect case data with respect to Phase 1 trials and the early development of equipment. Five studies and 86 cases have been registered so far. In clinical trials using an endoscope, an iPad was used to input data. Data collection was generally performed by CDISC Clinical Data Acquisition Standards Harmonization (CDASH) and the Study Data Tabulation Model (SDTM). The proposed system has been available to the public as freeware since 2014. Conclusion: In the institute, the adoption of IT in clinical trials has been promoted through the introduction of this system. We can now conduct trials, including multicenter studies, more easily. Operating as freeware, this system has the clear advantage of low introduction costs compared with other commercial EDC systems. A number of free-of-charge EDC systems already exist, such as OpenClinica and REDCap. The point that distinguishes our EDC system is its adoption of Case Report Form design methods via CAD software, which provides excellent usability. Moreover, the proposed system is compatible with the standard domains in CDISC CDASH and SDTM, and so input data can be output in CDISC format without further processing. In future, we will consider adding new functions, such as a connection to Healthcare Information Systems. Therefore, this system is expected to prove useful in investigator-initiated trials and so on. The above points suggest that the widespread use of the proposed system in academia will lead to effective, low-cost clinical trial No conflict of interest.