Development for cloud-based protocol management system

[Speaker] Hiroshi Sunada:1
[Co-author] Yusuke Endo:1, Miki Shimada:1, Masaki Mochida:2, Tatsuro Kawai:2, Atsushi Takenaka:1
1:Advanced Medicine, Innovation and Clinical Research Center, Tottori University Hospital, Japan, 2:SECOM SANIN CO., LTD., Japan

To improve the quality of clinical study, it is desirable to be involved of many researchers contributed in various stage of the study, from the research planning until presenting a paper. For this purpose, a protocol management system in our institute is supported by the specialized research experts from the research planning based on the concept of "Quality by Design". The ultimate goal in our study is to foster the experts on clinical study. We reported here development of a cloud-based interactive learning system on protocol management available for many researchers.

The proposed system is composed of following 4 basic strategies:
1. Purpose-oriented format for prospective research/ retrospective research/ questionnaire survey,
2. Progress status confirmation during editing,
3. Paragraph co-editing and insertion function,
4. The web browser enables us to output the Word formatted file.
These characteristics are especially cared for security, privacy and confidentiality from the demand of cloud system.

Concerning the format setting, determination of the type of research is realized with any platform regardless Windows/Mac operating system. Even for the complex format, the output document has the universal standard which enables easy to use for multiple user contribution in commenting and paragraph editing. Thus this property contribute to improve the quality of research from the very early stage. The special consideration of the cloud system strengthens the safety of the system in security, privacy and confidentiality by establishment of Virtual Private Network (VPN) and the management of user's controllable function.

Under the web-based cloud system, the editable bread-board model of protocol management system has been developed. The system contributes not only support for the description of application form but also promote for familiarity in the quality of application from the very early stage of planning. For the future perspective, we should consider the more user-friendly interface with high standards of usability and operation.

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