A Translational Research ( TR ) Protocol Generator and Monitor

نویسندگان

  • Jun Nakaya
  • Tetsuo Shimizu
  • Hiroshi Tanaka
چکیده

Conflict resolution of the clinical safety and the clinical efficiency is the first hurdle for the success of TR that is a kind of experimental phase of human based clinical trial. Maximizing both safety and efficiency produces conflicts, and it requires optimization of the TR protocol. Protocol management tool named "e-Protocol" having function of the protocol generation and the protocol monitoring can help optimization of the TR protocol. The protocol generator assists the generation of an optimized TR protocol by modifying the standardized TR protocols with four steps. The protocol monitor keeps watch on the execution status of the generated protocol and records the status of the results. This paper shows a basic concept, prototyping, and its evaluation of a TR protocol generator and monitor.

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تاریخ انتشار 2006