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RegisterRegarding completion of period from a subject [GxP / QC / QA]
Dear Mr Vivekanand,
No. The period will not be considered as "Completed"
If withdrawn during wash out period:
Yes. Usually, will be considered as that particular period is completed for the subject.
If withdrawn during ambulatory sample visits:
No. Should be considered as "Period Not completed"
❝ I. If a subject after dosing with drawn from a study in period-01 before check-out (in house stay). Then he/she shall be considered as period-not completed -is this yes/no.
No. The period will not be considered as "Completed"
❝ II. If a subject is with drawan from the study during wasout period of drug or during ambulatory sample visits for any AE.Then he/she shall be considered as period-not completed (for the period which they were dosed) -is this yes/no.
If withdrawn during wash out period:
Yes. Usually, will be considered as that particular period is completed for the subject.
If withdrawn during ambulatory sample visits:
No. Should be considered as "Period Not completed"
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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:
- Regarding completion of period from a subject vivekanand 2012-11-16 11:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Regarding completion of period from a subjectdrgunasakaran1 2012-11-16 15:51
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