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ratnakar1811 ★ India, 2014-06-19 10:37 (3979 d 06:05 ago) Posting: # 13090 Views: 7,340 |
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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] |
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Ohlbe ★★★ France, 2014-06-19 13:21 (3979 d 03:21 ago) @ ratnakar1811 Posting: # 13092 Views: 6,149 |
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Dear Ratnakar, Pregnancy is not per se an adverse event... One exception I would see to this is the situation where it is due to a drug-drug interaction with the contraceptive taken by the subject, leading to an unwanted pregnancy (or inefficiency of a IUD due to an anti-inflammatory effect, for instance). ❝ Should it be [...] followed up till the birth of the child Yes, certainly, as a congenital anomaly or birth defect would be a SAE. — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2014-06-19 21:33 (3978 d 19:09 ago) @ ratnakar1811 Posting: # 13094 Views: 6,055 |
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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. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2014-06-20 00:40 (3978 d 16:02 ago) @ ElMaestro Posting: # 13095 Views: 6,061 |
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Dear El Maestro, I fully agree, but... ❝ If the IMP is teratogenic or if the label carries a warning against use during pregnancy ... then I would expect the trial to be done only in male volunteers. — Regards Ohlbe |
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ElMaestro ★★★ Denmark, 2014-06-20 02:49 (3978 d 13:53 ago) @ Ohlbe Posting: # 13096 Views: 6,088 |
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Dear Ohlbe, ❝ ... then I would expect the trial to be done only in male volunteers. That makes good sense. Quick example illustrating my post above: here. The ref. UK SPC reads (section 4.6): "(...) moxifloxacin must not be used in pregnant women (...)" — Pass or fail! ElMaestro |
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ratnakar1811 ★ India, 2014-06-20 13:14 (3978 d 03:28 ago) @ ElMaestro Posting: # 13101 Views: 6,044 |
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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 |
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mittyri ★★ Russia, 2014-07-22 21:33 (3945 d 19:09 ago) @ ratnakar1811 Posting: # 13293 Views: 5,890 |
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Dear Ratnakar, ❝ 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 |
Ing. Helmut Schütz