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raghavendra_s ★ 2010-02-27 05:31 (5551 d 16:55 ago) Posting: # 4829 Views: 5,736 |
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Dear Sir, In a BA/BE study if the query for Investigational products is not resolved on the check-in day or say if it is delayed and get resolved on the dosing day early morning, can the IP accountability and identification can be done or we should wait for the sponsor's response? Thanks in advance, |
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Ohlbe ★★★ France, 2010-02-27 13:45 (5551 d 08:40 ago) @ raghavendra_s Posting: # 4831 Views: 4,646 |
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Dear Raghavendra, ❝ Dear Sir, We also have some Ladies on the forum. Don't discourage them from answering. ❝ In a BA/BE study if the query for Investigational products is not resolved ❝ we should wait for the sponsor's response? What query ? What response ? Sorry but I just don't understand what you're talking about. Regards Ohlbe — Regards Ohlbe |
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raghavendra_s ★ 2010-03-01 08:15 (5549 d 14:11 ago) (edited on 2010-03-01 11:49) @ Ohlbe Posting: # 4837 Views: 4,661 |
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Dear Madam/Sir, Say any query related to IP which might supposed to be answered by sponsor only. Then what further action we may require to move-forward ? Kind regards, Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime] |
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Ohlbe ★★★ France, 2010-03-01 13:07 (5549 d 09:19 ago) @ raghavendra_s Posting: # 4838 Views: 4,782 |
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Dear Raghavendra, Once again it depends on the question... If the answer is absolutely needed before you can administer the product to the subjects (for instance the expiry date), then telling the sponsor no answer would result in postponing the trial usually helps to get a fast answer. Whether you can already dispense/package the IMP depends on its primary packaging and on how you do the packaging yourself, I would say. If it is in a large bottle, or if you remove it from its blister: this is usually done on the day before dosing, for stability reasons. So if you're not sure to be able to dose, doing the dispensing/packaging may be a problem. If the IMP remains in its blister, then no problem to do the dispensing/packaging in advance. Regards Ohlbe — Regards Ohlbe |
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