subject inclusion question in replicate design for ANVISA [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2019-09-04 22:23 (1667 d 05:21 ago) – Posting: # 20542
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Hi Shuanghe,

❝ […] the client's statistical consultant commented that only subjects who complete all 4 period (2T+2R) should be included, otherwise, they should be excluded even if they completed 3 period.


IMHO, this doesn’t make sense. See the example in the vignette of replicateBE. At least this is what I have I done in my European studies and never got a question about it.

❝ By the way, Helmut, does this belong to Study Assessment or Regulative/Guideline category?


Study Assessment is about ongoing/completed studies. I moved it here.

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