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hiren379 ★ India, 2012-08-29 18:19 (5053 d 02:01 ago) Posting: # 9123 Views: 3,294 |
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Hello Friends, Canada Guideline states below for concideration of drop out subjects for Bioanalysis. "Reasons for withdrawal of subjects administered at least one dose of drug (e.g., adverse drug reaction) should be reported, and the subject's plasma (or blood or serum) concentration data should be provided. The results of the bioanalysis of all samples from subjects who were withdrawn from the study should be reported. If a subject withdraws from the study for personal reasons or because of non-compliance with the protocol (e.g., positive drug test) before completing at least two periods of the study, the subject’s blood samples do not have to be analysed." Please guide on below cases.
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drgunasakaran1 ★★  2012-08-29 19:51 (5053 d 00:30 ago) @ hiren379 Posting: # 9124 Views: 2,716 |
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Dear Mr Hiren, ❝ 1. Replicate study and subject completes 2 period and then withdraw consent (personal reason). Should samples be analysed? Yes. Samples should be analysed. ❝ 2. Replicate study and subject completes 2 period and then withdrawn due to adverse event. Should samples be analysed? Yes. Samples should be analysed. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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pash413 ★ India, 2012-08-30 17:28 (5052 d 02:52 ago) @ drgunasakaran1 Posting: # 9127 Views: 2,707 |
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what should we conclude from the analyzed data? Weather this data will be useful in statistical analysis or knowing any absurd property of formulation? 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! [Helmut] |
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Helmut ★★★   Vienna, Austria, 2012-08-30 17:41 (5052 d 02:39 ago) @ pash413 Posting: # 9128 Views: 2,719 |
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Hi Hiren! ❝ what should we conclude from the analyzed data? Sometimes volunteers don’t report AEs – fearing that they will not be included in other studies – and withdraw from the study “for personal reasons” instead. ❝ […] knowing any absurd property of formulation? Rather a (rare?) condition of the subject? See the end of this post and the footnote of this post. — 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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paulhurleyuk ☆ NE UK, 2012-08-31 12:34 (5051 d 07:46 ago) @ drgunasakaran1 Posting: # 9133 Views: 2,611 |
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Obviously this will differ on a case by case basis, but in some cases a patient may withdraw their consent for any part of their contribution to be used for this study (theoretically, they may find they disagree with the ethics of how the study was run). IMHO GCP then requires you to stop analysing their samples and dispose of them, and possibly not report the data either. |
Ing. Helmut Schütz