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BEAZ ★ India, 2008-12-02 09:02 (6418 d 00:49 ago) Posting: # 2855 Views: 3,667 |
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Dear all, Can any one tell is it acceptable to take back the retention sample from the CRO? For example for a passed pivotal study if the sponsor ask the CRO to send back the retention how it has to dealt with? is it acceptable ?  — Alhas |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-12-02 10:14 (6417 d 23:37 ago) @ BEAZ Posting: # 2857 Views: 2,909 |
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Dear Alhas, ❝ Can any one tell is it acceptable to take back the retention sample from the CRO? Why not? I don't think there is any harm in getting / sending back the samples. May be some sample are exhausted (Due to consumption at BA end for analysis and reanalysis) Regards Joshi — Best Regards Joshi |
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Ohlbe ★★★ France, 2008-12-02 10:45 (6417 d 23:06 ago) @ BEAZ Posting: # 2859 Views: 2,992 |
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Dear Alhas, For an FDA submission the answer is clearly: NO. In case of an inspection the trial will be rejected, even if the retention samples are sent back to the CRO. EMEA: the guideline does not require retention samples to be kept at the site. So no problem to send them back to the sponsor. Document what you do, how much you send back, the batch numbers, etc. I would suggest to keep photocopies or pictures of the containers for both the test product and the reference product. Other markets: check in the respective guidelines. Regards Ohlbe |
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BEAZ ★ India, 2008-12-02 11:02 (6417 d 22:49 ago) @ Ohlbe Posting: # 2860 Views: 2,938 |
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Dear Ohlbe and Joshi Thank you Regards ALHAS -- Edited to remove quotation marks [Ohlbe] — Alhas |
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han16 ● 2009-02-17 12:56 (6340 d 20:55 ago) (edited on 2009-02-18 19:30) @ Ohlbe Posting: # 3257 Views: 2,646 |
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Dear Ohlbe ❝ I would suggest to keep photocopies or pictures of the containers for both the test product and the reference product. I did not understand what did you mean by keeping "pictures of the containers" If the compound is Photosensitive then in that regard we will not be able to take photocopies or picture of the aliquoted / seeded containers. We can retain the sample details received from the client or the clinical centre. And document in the freezer register (log book), and fill in the template for sending the samples by entering details as you rightly said in your reply ❝ Document what you do, how much you send back, the batch numbers, etc. -- Edited to restore quotation marks [Ohlbe] |
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Ohlbe ★★★ France, 2009-02-18 20:34 (6339 d 13:17 ago) @ han16 Posting: # 3272 Views: 2,668 |
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Dear han16, ❝ If the compound is Photosensitive then in that regard we will not be able to take photocopies or picture of the aliquoted / seeded containers. Come on ! If the product is so photosensitive it should be provided with a light-protecting packaging. And anyway with a solid dosage form exposure to light for a few seconds will do nothing to your product. Taking a picture or a photocopy of the outer and of the primary packaging of the products you were provided with raises no difficulty. Regards Ohlbe |
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Helmut ★★★   Vienna, Austria, 2009-02-18 22:25 (6339 d 11:26 ago) @ Ohlbe Posting: # 3273 Views: 2,713 |
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Dear Ohlbe!  Taking a photograph (without a flash) is like looking at something. If the formulation is that sensitive, patients should take it only in the dark!  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Ohlbe ★★★ France, 2009-02-19 00:45 (6339 d 09:06 ago) @ Helmut Posting: # 3274 Views: 2,619 |
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Dear Helmut, ❝ Taking a photograph (without a flash) is like looking at something. Oh, even the flash wouldn't do much harm ! Best regards Ohlbe |
Ing. Helmut Schütz