Check in delay [GxP / QC / QA]
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,
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,
Complete thread:
- Check in delayraghavendra_s 2010-02-18 06:18
- Check in delay raghu 2010-02-18 19:02
- Check in delay bharat 2010-03-09 07:05
