raghavendra_s
★    

2010-02-18 07:18
(5959 d 11:27 ago)

Posting: # 4782
Views: 6,178
 

 Check in delay [GxP / QC / QA]

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Dear Sir,

In a BA/BE study, on the day of check-in due to unavoidable reasons if the check-in happens late night say about 12midnight, is it ok with the restrictions and prohibitions mentioned in the protocol as they are going to file protocol deviation for the same. (eg: fasting restrictions of at least 10 hours before receiving the study drug?).

Kindly suggest.

Thanks and regards,
 
raghu
★    

India,
2010-02-18 20:02
(5958 d 22:43 ago)

@ raghavendra_s
Posting: # 4791
Views: 4,936
 

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Dear Raghavendra,

❝ In a BA/BE study, on the day of check-in due to unavoidable reasons if the check-in happens late night say about 12midnight


OK

❝ is it ok with the restrictions and prohibitions mentioned in the protocol as they are going to file protocol deviation for the same. (eg: fasting restrictions of at least 10 hours before receiving the study drug?).


NOT OK

If the fasting condition is not maintained either at least 10 hours before dose or at least 4 hours post dose is a major deviation and your study might be questionable.

Regards
Raghavender.Chenna
 
bharat
☆    

India,
2010-03-09 08:05
(5940 d 10:40 ago)

@ raghavendra_s
Posting: # 4879
Views: 4,850
 

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Dear Raghvendra,

At least fasting restriction should me maintained.

Thanks and regards,
Bharat Narnavar

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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