Randomization for withdrawals / stand-by subjects [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2022-08-22 11:36 (604 d 05:32 ago) – Posting: # 23226
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Hi neilfiona,

in my old CRO we had exactly your procedure and it was never a problem in CGP inspections. There is only a cosmetic issue, namely that you have ‘holes’ in the subject numbers. But you will face the same with dropouts during the study.

In other CROs subjects are assigned to the randomization once it is known who will agree to participate. Then you don’t have to create a randomization larger than the planned sample size. Acceptable as well.

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