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Survivor2012

12/06/17 10:48 AM

#147919 RE: notbrad #147912

Not bad notbrad!!

Evaluate

12/06/17 3:39 PM

#148031 RE: notbrad #147912

you wrote:

But the FDA could be collecting unblinded data directly through the CRO/DMC.


How long could the FDA already have access to unblinded data?
Can the FDA enforce them being able to view unblinded data? Could the FDA already have had access since/during the enrollment hold?