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Mrugank ☆ India, 2012-08-18 20:22 (4647 d 07:50 ago) Posting: # 9079 Views: 4,983 |
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Dear All, In double blind, three treatment study design - what are the resolution steps if Dosing treatment of two subjects have been interchange during Period - 1 ? Should we consider those two subjects continue for remaining study - if still Period 2 and Period 3 are remain ? Is there any effect of it on result of study data? Regards, Mrugank Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2012-08-20 01:47 (4646 d 02:25 ago) @ Mrugank Posting: # 9082 Views: 4,126 |
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Dear Mrugank! ❝ In double blind, three treatment study design - what are the resolution steps if Dosing treatment of two subjects have been interchange during Period - 1 ? If this is a double blind study – how do you know the randomization was screwed up? Did the PI open the emergency envelopes and if yes, why? — 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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Mrugank ☆ India, 2012-08-20 18:37 (4645 d 09:36 ago) @ Helmut Posting: # 9084 Views: 4,116 |
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Dear Helmut, Randomization schedule has not been opened by PI till yet. Matter is we have dosed to two subjects interchangeably. e.g. Subject Number 02 has been administered a treatment of subject Number 03 and vice versa. Weather is it acceptable in any way ? Should we consider this two subjects continue for remaining study by shifting of treatment of both subjects in all 3 period? Regards, Mrugank |
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Helmut ★★★ Vienna, Austria, 2012-08-20 18:52 (4645 d 09:20 ago) @ Mrugank Posting: # 9085 Views: 4,186 |
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Dear Mrugank! ❝ Randomization schedule has not been opened by PI till yet. Matter is we have dosed to two subjects interchangeably. ❝ e.g. Subject Number 02 has been administered a treatment of subject Number 03 and vice versa. Sorry, I misinterpreted your first post. ❝ Weather is it acceptable in any way ? Should we consider this two subjects continue for remaining study by shifting of treatment of both subjects in all 3 period? It should be possible, but:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz