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Re: rizona post# 24419

Monday, 08/19/2019 10:38:11 AM

Monday, August 19, 2019 10:38:11 AM

Post# of 43856
They got it through the development safety update report that was communicated to the hospital IRB by the sponsor : that's a standardized mandatory annual report required by the FDA and other agencies in the world which the sponsor has to produce (or at least the CRO on behalf of). Don't forget that the CRO has a consolidated view of all events site by site, not necessarily by arm (test or control), but at least a consolidated view.
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