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RegisterHousing deviation [Study Performance]
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.
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
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
Complete thread:
- Housing deviation suchit_bhavsar 2012-02-17 06:20
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Housing deviation drgunasakaran1 2012-02-17 06:29
- Housing deviation suchit_bhavsar 2012-02-17 06:52
- Housing deviationdrgunasakaran1 2012-02-17 07:22
- Housing deviation suchit_bhavsar 2012-02-17 06:52
- Housing deviation drgunasakaran1 2012-02-17 06:29
Ing. Helmut Schütz