Log in
RegisterShould pregnancy be considered as SAE? [Study Performance]
Dear Ratnakar,
There are some debates on the internet about this issue(Pregnancy=SAE?)
I agree with colleagues who's thinking that pregnancy occurring during a volunteer’s participation in a clinical trial, although not typically considered an SAE, must be notified to the sponsor within the same timelines as an SAE (within one working day) on a Pregnancy Monitoring Form. This also applies to pregnancies following the administration of the investigational product to the father prior to sexual intercourse.
Also you can see this GCP Discussion
❝ 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".
There are some debates on the internet about this issue(Pregnancy=SAE?)
I agree with colleagues who's thinking that pregnancy occurring during a volunteer’s participation in a clinical trial, although not typically considered an SAE, must be notified to the sponsor within the same timelines as an SAE (within one working day) on a Pregnancy Monitoring Form. This also applies to pregnancies following the administration of the investigational product to the father prior to sexual intercourse.
Also you can see this GCP Discussion
—
Kind regards,
Mittyri
Kind regards,
Mittyri
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