Bioequivalence and Bioavailability Forum

Dear all,

On the site's SOP, when the screening measurement is ok, the subject will take the random number at day -1 then live at the site. However, after one night, few subjects want to quit before dispensing at day 0.

My question is if I can prepare few random numbers for backup? The researcher would let those backup subjects live at the site after the screening measurement. If the situation above occurs, we could take the backup number for those backup subjects.

And then, how to do random number backup? Because I don't know which treatment sequence group's subject will quit, and the BE study is opened for researcher. I'll prepare 1-2 blocks of random number for backup, so the researcher can select right backup random number for backup subject which have the same treatment sequence with the dropout subject.

Please give me some suggestion. Thanks.

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Edit: Category changed; see also this post #1. [Helmut]