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RegisterSubject did not swallow the tablets [Study Assessment]
Hi Ken Peh,
Well, if I get you right you do not know with certainty why the results was BLQ throughout the sequence. So you can't give a reason. This is what the study report should reflect. You should of course demonstrate ability to investigate all relevant sources of error: CRFs, dosing, bioanalysis runs, etc.
It stinks, agreed. But when you have identified no apparent reason, no reason can be reported.
❝ Do we need to provide reasons for the abnormal results in the discussion ? What could be the logical reason or explanation to give in the report ? 
Well, if I get you right you do not know with certainty why the results was BLQ throughout the sequence. So you can't give a reason. This is what the study report should reflect. You should of course demonstrate ability to investigate all relevant sources of error: CRFs, dosing, bioanalysis runs, etc.
It stinks, agreed. But when you have identified no apparent reason, no reason can be reported.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Subject did not swallow the tablets Ken Peh 2014-06-20 05:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Subject did not swallow the tablets ElMaestro 2014-06-20 08:01
- Subject did not swallow the tablets Dr_Dan 2014-06-20 10:08
- Subject did not swallow the tablets Ken Peh 2014-06-20 15:33
- Subject did not swallow the tabletsElMaestro 2014-06-20 15:45
- Subject did not swallow the tablets Ken Peh 2014-06-23 08:45
- Subject did not swallow the tabletsElMaestro 2014-06-20 15:45
- Subject did not swallow the tablets Ken Peh 2014-06-20 15:33
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