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  • Customizing Subject Unblinding …

    Case StudiesAug 24

    Problem: Protocol complexities often call for a customized approach to unblinding subjects in your clinical trial. First, authorized users need to receive an on-screen message with a very specific set of instructions when they begin to unblind a subject. Second, they need to be presented with a Yes/No option to confirm that the Site Monitor or Sponsor has been alerted. Third, the user needs to request and receive an immediate authorization code from a 24-hour Medical Monitor. That code must +