The patient does not meet inc/excl criteria, but on the marginal level, e.g. age above 20 years old is eligible, but this patient only 19 years plus 8 months, so investigator asks for waiver, if waiver is approved by the sponsor or medical monitor, this patient can be enroled into the study, but around recent 2 years, EMEA has a tighter waiver policy, so most companies do not grant waiver.
robbie (2008-9-21 13:58:04)
if the inv enrolled the 19 year + 8 month patient, when CRA identified this issue, should the subject withdraw and follow up safety or keep subject in the study?
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Jamesdfan (2008-8-29 23:04:52)
robbie (2008-9-21 13:58:04)
xiaxiaoxiao (2008-9-26 10:19:33)