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suchit_bhavsar ★ India, 2012-02-17 07:20 (4833 d 10:03 ago) Posting: # 8135 Views: 4,447 |
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Hello to all of you "As per approved study protocol subjects will be housed at the clinical facility from not less than 10.5 hours pre-dose till at least 48 hours post-dose in each period" Now suppose one subject wants to go home due to personal reason and he/she does not want to continue in the study so in this case it is requied to file housing deviation for the same ? If yes then what would be impact of that ? Waiting for reply Regards, Suchit Bhavsar Alembic Research Center |
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drgunasakaran1 ★★  2012-02-17 07:29 (4833 d 09:54 ago) @ suchit_bhavsar Posting: # 8136 Views: 3,666 |
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Dear Mr.Suchit Bhavsar, If the subject withdrew his consent to continue to participate in the study, you need to file "Subject withdrawal Form" and under the Section "Reasons for Withdrawal" you have to mention that Subject withdraw his consent to continue to participate in the study due to personal reasons. There is no need to file Housing deviation since the subject is already withdrawn from the study. — 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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suchit_bhavsar ★ India, 2012-02-17 07:52 (4833 d 09:32 ago) (edited on 2012-02-17 09:58) @ drgunasakaran1 Posting: # 8137 Views: 3,614 |
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Dear Sir, Thanks for the prompt reply. And again one case in that subject wishes to go home on housing day for personnel reason and he /she is telling that he will come to give remaining samples on time to time. In this case housing deviation required or not ? Regards, Suchit Bhavsar Alembic Research Center 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! [Ohlbe] |
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drgunasakaran1 ★★ 2012-02-17 08:22 (4833 d 09:02 ago) @ suchit_bhavsar Posting: # 8138 Views: 3,691 |
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Dear Mr.Suchit Bhavsar, It will not be accepted by the regulatory agency, if you allow the subject to go home and come to the clinic to give the remaining samples from time to time. It is not possible to maintain uniformity in the standardization of meal consumption if the subject is not confined to the clinic. You cannot ensure that the subject is consuming any prohibited substances, or maintaining any restriction compliance during the study period as stated in the protocol. You need to withdraw the subject in this case. — 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 |
Ing. Helmut Schütz