Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
Quality Control in Clinical Trials Blinding, Clinical ... - summitMD.com
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Independence of DSMB (2)<br />
• Sponsor <strong>in</strong>teraction with DSMB<br />
• “Open” part of meet<strong>in</strong>g to review<br />
enrollment, <strong>com</strong>pliance, event rates <strong>in</strong><br />
aggregate as well as sponsor goals,<br />
plans, and resources<br />
• DSMB can address questions from<br />
<strong>in</strong>terim <strong>com</strong>parative data review to<br />
sponsor