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RegisterOutlier in BE [Study Assessment]
Hi Gopinath,
how about auditing the study before you take any further decisions?
I am hearing you more or less say that you think the products in spite of the data are BE. That's why you want to exclude the subject in question, and that's why you think there is a grounds to believe the subject in question does not reflect the product's average performance, variance taken into consideration .
Therefore, a for-cause audit might have merit. If your audit illustrates a general issue at the CRO then that's some pretty valuable knowledge to have prior to deciding on a repeat study (and especially where it is to take place).
how about auditing the study before you take any further decisions?
I am hearing you more or less say that you think the products in spite of the data are BE. That's why you want to exclude the subject in question, and that's why you think there is a grounds to believe the subject in question does not reflect the product's average performance, variance taken into consideration .
Therefore, a for-cause audit might have merit. If your audit illustrates a general issue at the CRO then that's some pretty valuable knowledge to have prior to deciding on a repeat study (and especially where it is to take place).
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Outlier in BE ramgopi 2018-03-14 11:29 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Low AUC after reference product Helmut 2018-03-14 16:38
- Low AUC after reference product mittyri 2018-03-15 10:56
- Outlier in BE ramgopi 2018-03-18 07:44
- Outlier in BEElMaestro 2018-03-18 14:43
- Outlier in BE ramgopi 2018-03-19 10:55
- Outlier in BEElMaestro 2018-03-18 14:43
- Low AUC after reference product Helmut 2018-03-14 16:38
Ing. Helmut Schütz