Different sections for a training certification

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      Mai Nishihara

      It might have discussed earlier, but could anybody enlighten me on how to distinguish two sections, 1.4.2 and 1.4.4 for a study team’s training certification?

      A study team’s training certification, such as system training and SOP training seems to fit for 1.4.4 from the explanation “definition/ purpose”, yet 1.4.4 represents the evidence of ICH 5.4.1, where specific individuals (e.g. biostatistician, clinical pharmacologist, and physicians) are apparently focused.

      Or should a study team’s certification be stored for 1.4.2, which is related to ICH 2.4 covering each individual involved in conducting a trial ?

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