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Registersubject inclusion question in replicate design for ANVISA [RSABE / ABEL]
posted by Helmut 
– Vienna, Austria, 2019-09-04 20:23 (550 d 11:45 ago) – Posting: # 20542
Views: 1,487
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
» 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.
» […] 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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Dif-tor heh smusma 🖖
Helmut Schütz
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Dif-tor heh smusma 🖖
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-04 14:48 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- subject inclusion question in replicate design for ANVISAHelmut 2019-09-04 20:23
- subject inclusion question in replicate design for ANVISA Shuanghe 2019-09-05 14:38
- subject inclusion question in replicate design for ANVISAHelmut 2019-09-04 20:23
Ing. Helmut Schütz