Bioequivalence and Bioavailability Forum

Should pregnancy be considered as SAE? [Study Performance]

posted by ratnakar1811 – India, 2014-06-19 10:37 (4388 d 22:40 ago) – Posting: # 13090
Views: 9,295

Dear All,

I just have a doubt about the reporting of pregancy of a female subejct during the study. Should it be reported as SAE and followed up till the birth of the child and what are the reporting requirments generaly followed?

Thanking you in advance for your vaulable comments.

Regards,

Ratnakar

Edit: Category changed. [Helmut]

Complete thread:

Should pregnancy be considered as SAE?ratnakar1811 2014-06-19 08:37
- 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? [Study Per­for­mance]

Complete thread:

Should pregnancy be considered as SAE? [Study Performance]