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deuce金蟲 (小有名氣)
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There appears to be some room for manoeuvre in the legislation with regard to the interpretation of ‘‘good clinical practice.’’ Instead of accepting each new layer of bureaucracy the academic com-munity should clarify these developments, using legal advice where necessary. The cost-effectiveness of the type of procedures that ICH GCP generates is untested. For example, it has been estimated that the cost of a single ‘‘data query’’ is US$150. Robert Califf notes that this is a ‘‘colossal waste of money,’’ and that a more effective and scientific method would be to use sampling and the statistical process control techniques that are found in other indus-tries (such as engineering and manufac-turing) [41]. In short, there is no evidence that the intense bureaucracy of centralised politically driven procedures for ICH GCP has improved the care of trial participants in any way |
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