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Dear Colleagues,
How to select the stand-by subjects for statistical analysis.
For a Study of 24 +4 volunteers, if two subjcts are drop out /
withdrawn, (sub no 14 and 19 of randomization RT and RT respectively)
we have to select 2 subjects from stand-bys. Ok.
If the 4 standby subjects have been dosed as follows:
Sub No 25 T R, Sub No 26 R T, Sub NO 27 T R, Sub NO 28 R T,
My question is
1. Whether we have to select 25 and 26 or
2. Whether we have to select 26 and 28
Members can kindly throw their views.
T.R.Yegnaraman
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Dear Yegnaraman,
it's all what you have written in protocol and SOP. If in your
protocol, you have written " the same sequence of subjects will be
taken in case of dropout", than you have to select subject#26 & 28,
otherwise 25 & 26.
If nothing is specified in your protocol, then it's always beneficial
to take subjects with same sequence (26 & 28)
Hitesh Chauhan
Biostatistician
BA Research India Ltd.
Ahmedabad
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