2022-08-22 10:19
(400 d 07:09 ago)

Posting: # 23225
Views: 1,540

 Is random numbers backup acceptable? How to do? [Study Per­for­mance]

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.

Edit: Category changed; see also this post #1[Helmut]
Vienna, Austria,
2022-08-22 11:36
(400 d 05:52 ago)

@ neilfiona
Posting: # 23226
Views: 1,346

 Randomization for withdrawals / stand-by subjects

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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2022-08-22 12:00
(400 d 05:28 ago)

@ Helmut
Posting: # 23227
Views: 1,333

 Randomization for withdrawals / stand-by subjects

Thanks Helmut's reply.

I just got the definite statement for this issue from the up-to-date BE guideline of CDE. It's said that additional subjects is not accecptable when trail began.

I'll talk with the site how to handle this issue.


2022-08-22 12:43
(400 d 04:44 ago)

@ neilfiona
Posting: # 23228
Views: 1,359

 Stand-by subjects

Dear neilfiona,

What I see quite often is that a few additional subjects (often called stand-by subjects) are indeed housed overnight. If one of the subjects assigned a number decides to pull out of the study before dosing in period 1, he will be replaced by one of the stand-by subjects, keeping the same subject number with a prefix (e.g. if subject 12 drops out, the replacement subject will be identified as R12 or 112). The replacement subject uses the same randomisation as the subject who dropped out (if 12 was RT, then R12 is also RT). This avoids having to generate an extra randomisation list, with the risk of unbalance.

Unused stand-by subjects leave the site once the last subject has been dosed and it is confirmed they are not needed. Standard practice is to give them a financial compensation for their time, and to give them priority to participate actively in the next study.

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