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Medical Device CRO Blog

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Protocol “Waiver” from the Sponsor- Is That Enough?

Posted by Brandy Smith on Fri, Oct 12, 2012 @ 07:09 AM

At times, a Sponsor may provide a site with a memo allowing the site to enroll a patient who does not meet all inclusion or exclusion criteria. Or a Sponsor may give the site pre-approval to deviate from the protocol-defined visit windows. Is this waiver enough? Would the investigative site be covered in the event of a federal audit?

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