Log in
RegisterShould pregnancy be considered as SAE? [Study Performance]
Dear Both,
I fully agree with both of you, as pointed out by ElMaestro, we have adequately explained it in ICF. My only concern is, if such situation encounter in future, how do we deal with it? By reporting it as SAE or separately reporting it as a case of "Pregnancy report during study". As we all will agree that most of the SPC/ PIL will have a sentence, 'The safety of drug in human pregnancy has not been evaluated'.
Best Regards,
Ratnakar
I fully agree with both of you, as pointed out by ElMaestro, we have adequately explained it in ICF. My only concern is, if such situation encounter in future, how do we deal with it? By reporting it as SAE or separately reporting it as a case of "Pregnancy report during study". As we all will agree that most of the SPC/ PIL will have a sentence, 'The safety of drug in human pregnancy has not been evaluated'.
Best Regards,
Ratnakar
Complete thread:
- Should pregnancy be considered as SAE? ratnakar1811 2014-06-19 08:37
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 11:21
- Should pregnancy be considered as SAE? ElMaestro 2014-06-19 19:33
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 22:40
- Should pregnancy be considered as SAE? ElMaestro 2014-06-20 00:49
- Should pregnancy be considered as SAE?ratnakar1811 2014-06-20 11:14
- Should pregnancy be considered as SAE? mittyri 2014-07-22 19:33
- Should pregnancy be considered as SAE?ratnakar1811 2014-06-20 11:14
- Should pregnancy be considered as SAE? ElMaestro 2014-06-20 00:49
- Should pregnancy be considered as SAE? Ohlbe 2014-06-19 22:40
Ing. Helmut Schütz