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RegisterExtra (standby) subjects [Design Issues]
Hi there,
In BA/ BE studies, we usually dose approximately n=10% more than the required sample size to take care of the withdrawals and drop outs to meet the required sample size at the end of the study. But are there any guidelines for ethical considerations for this? And if those extra subjects also complete the study, what is the justification for including/ excluding these extra subjects' samples for bioanalysis and including their data in statistical analysis. Do we have any regulatory guidelines for this?
Thank you,
Dr. Brijesh.
Edit: Category changed. [Helmut]
In BA/ BE studies, we usually dose approximately n=10% more than the required sample size to take care of the withdrawals and drop outs to meet the required sample size at the end of the study. But are there any guidelines for ethical considerations for this? And if those extra subjects also complete the study, what is the justification for including/ excluding these extra subjects' samples for bioanalysis and including their data in statistical analysis. Do we have any regulatory guidelines for this?
Thank you,
Dr. Brijesh.
Edit: Category changed. [Helmut]
Complete thread:
- Extra (standby) subjectsbrijeshmaroj 2011-02-08 07:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Extra (standby) subjects Ohlbe 2011-02-08 10:10
- Extra (standby) subjects brijeshmaroj 2011-02-08 11:18
- Extra (standby) subjects Helmut 2011-02-08 12:47
- Extra (standby) subjects brijeshmaroj 2011-02-08 11:18
- Extra (standby) subjects Ohlbe 2011-02-08 10:10
Ing. Helmut Schütz