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Structure of the White Paper 1 Discussion White Paper The outdated paradigm [Comment Hon Sum] This section begins with traditional approach to store and access “data.” However, subsequent discussions are on “information” (historical and current), “key words or phrases” as well as issues about sharing between cultures – such information could be metadata instead of real data. The concepts within this section should be clarified. For .instances, it says globalization has challenged databases, but databases cannot be challenged; rather, as it states later, the challenge is about informational interpretation instead of data or databases 2 Discussion White Paper (2) Current Use of Semantic Technology COMMENT HON SUM [The last paragraph contains conclusions not supported by earlier dissertation: “It is clear, however, that the transition to semantic …..” It is actually not clear how transition to semantic technology necessarily requires change in mindset about sharing. The advantages derived from sharing as stated subsequently in the paragraph (promoting collaboration, attracting buyers, outsource to reputable agents) exist regardless of the use of semantic technology. It is not obvious how a change of mindset about sharing is a prerequisite to a transition to semantic technology.] 3 Design Framework Teamwork (Top) 4 Design Framework Teamwork (Bottom) 5 Design Framework WP: Checklist Table 1: Outcome checklist to validate a clinical design program framework prior to protocol development Patient - Will the patients join the trial? - Are all measure collected used? - Are the measure collected support endpoints? Site Sponsor - Are objectives and endpoints - Are endpoints supporting connected? design questions? - Are the objectives describing - Are endpoints supported by current procedures and clinical the right information from practice? population, trial design, comparator, drug and geographic location? 6 Modeling Tools 7