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RegisterShould pregnancy be considered as SAE? [Study Performance]
Hello Ratnakar
a disgression:
Apart from what Ohlbe said, I think such a case would also be an opportunity for you to review the procedure around informed consent/enrollment interviews etc; perhaps something about the need for sexual abstinense and/or use of controlling remedies was vague or inadequately explained.
If the IMP is teratogenic or if the label carries a warning against use during pregnancy then you'd definitely have a good reason for reviewing certain things internally and possibly with the volunteer as a pre-preventive measure.
a disgression:
Apart from what Ohlbe said, I think such a case would also be an opportunity for you to review the procedure around informed consent/enrollment interviews etc; perhaps something about the need for sexual abstinense and/or use of controlling remedies was vague or inadequately explained.
If the IMP is teratogenic or if the label carries a warning against use during pregnancy then you'd definitely have a good reason for reviewing certain things internally and possibly with the volunteer as a pre-preventive measure.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
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
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