Regarding Distribution of ICFs to volunteers [Study Per­for­mance]

posted by suchit_bhavsar – India, 2012-06-05 09:26 (4724 d 14:56 ago) – Posting: # 8660
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Hello to all,

We had conducted pivotal study on 50 subjects. On the day of check in we had presented ICFs to 55 volunteers. Out of them few volunteers found alcohol positive and positive for urine drug scan of abuse. So if they (Alcohol poitive and urine drug scan poitive volunteers) are asking for the ICF copies (They had signed) so it is mandatary to give copy of it to them ?

Regards,
Suchit Bhavsar

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