Housing deviation [Study Performance]
Hello to all of you
"As per approved study protocol subjects will be housed at the clinical facility from not less than 10.5 hours pre-dose till at least 48 hours post-dose in each period" Now suppose one subject wants to go home due to personal reason and he/she does not want to continue in the study so in this case it is requied to file housing deviation for the same ?
If yes then what would be impact of that ?
Waiting for reply
Regards,
Suchit Bhavsar
Alembic Research Center
"As per approved study protocol subjects will be housed at the clinical facility from not less than 10.5 hours pre-dose till at least 48 hours post-dose in each period" Now suppose one subject wants to go home due to personal reason and he/she does not want to continue in the study so in this case it is requied to file housing deviation for the same ?
If yes then what would be impact of that ?
Waiting for reply
Regards,
Suchit Bhavsar
Alembic Research Center
Complete thread:
- Housing deviationsuchit_bhavsar 2012-02-17 06:20
- Housing deviation drgunasakaran1 2012-02-17 06:29
- Housing deviation suchit_bhavsar 2012-02-17 06:52
- Housing deviation drgunasakaran1 2012-02-17 07:22
- Housing deviation suchit_bhavsar 2012-02-17 06:52
- Housing deviation drgunasakaran1 2012-02-17 06:29