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RegisterInclusion and Exclusion criteria [GxP / QC / QA]
Dear All,
In the protocol for an antihypersensitive drug, as an exclusion criteria it was mentioned as diastolic blood pressure less than 80mmHg or more than 90mm Hg.
My question is wheather exclusion criteria shall be maintained only during period 01 Check-in or for all the periods check-in. and also if suppose we have not comply to the exclusion criteris for period 02 what should be our stand.
Regards,
Varsha
In the protocol for an antihypersensitive drug, as an exclusion criteria it was mentioned as diastolic blood pressure less than 80mmHg or more than 90mm Hg.
My question is wheather exclusion criteria shall be maintained only during period 01 Check-in or for all the periods check-in. and also if suppose we have not comply to the exclusion criteris for period 02 what should be our stand.
Regards,
Varsha
Complete thread:
- Inclusion and Exclusion criteriaVarsha 2012-06-15 12:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Inclusion and Exclusion criteria kaushik089 2012-06-15 13:31
- Inclusion and Exclusion criteria Varsha 2012-06-16 08:40
- Inclusion and Exclusion criteria kaushik089 2012-06-15 13:31
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