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respected all members
here i have queries
has subject fasted foe at least 10 hrs is question and answer is Yes
or No
2.Has subject drinking any wter since 7am answer is Yes or No
i s such type questions at the time of dosing necessrey to ask
volunteer or confirm ourself without aking him
regrds
atul
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Dear Atul
The water restriction along with other prohibitions and fasting
period are needs be confirmed. It is the responsibility of study
personnel (Custodian) to enforce these restrictions/prohibitions.
The custodian should give the report regarding the enforcement of
prohibitions. There is no need of enquiring from the study subjects.
D Mallikarjuna Rao, Ph.D.
Principal Scientist-Clinical Development
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