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

posted by Helmut Homepage – Vienna, Austria, 2019-09-04 18:23  – Posting: # 20542
Views: 705

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.

Cheers,
Helmut Schütz
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