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Dear All,
If subjects are kept in house and their activity
is to be noted, what are the parameters are to be noted. If subjects
are kept in-house thought all the periods including washout periods
then what are the ideals to be followed. What is activity chart for
this , what should be its contents.
- antaryami
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The following message was posted to: PharmPK
Dear Antaryami,
During in-house period, you have to note water restriction period, vital
signs, and subject well being and diet, etc.
If washout period is long, there is need not necessary to stay the
volunteers at study center. If the washout period is less (i.e. 3
days) at
this case it is necessary to stay the volunteers at study center. the
main
criteria is subjects safety and well being.
the formats to be filled for all the perameters can design according
to your
procedures. You can design your own formats for noting of all the
perameters.
regards
Srinivasa Reddy.E
Research Analyst
Bioserve Clinical Research
Hyderabad
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Dear Dr.Maharana,
If I understand your question, the following will be useful to you.
Even though, guidelines dosen't elaborate about this, When the
volunteers are in house, the following activities have to be noted
* Check-in
* Vital parameters
* Physical examination chart
* Meals consumption chart
* Bed time
* Wake-up time
* Cannuale insertion time and removal time if it is used
* Blood sampling points or else Urine collection points and volume of
urine collected
* Mi
* Well - being chart
*
* Check-out
After washout, in the second period
* Check, whether they have consumed OTC drugs or any other drugs
* Consumption of tobbaco and alcohol ( even though we can't get the
genuine feedback in this regard)
Since we don't have guideline for this, we should have to cover all
the activities, which can affect the study outcome.
Regards.
Francis
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