Protecting the Study Blind in IRT Processing

Case Studies, IRT Essentials

In recent years there has been an upsurge in professional vigilance with regard to maintaining the study blind in clinical trials. Concern about incidental unblinding — i.e., an unblinding or ‘partial unblinding’ that occurs accidentally in the course of modifying some other aspect of a trial– has grown in proportion to new strategies and techniques adopted by the industry. These concerns apply to all sectors of a study strategy, including outsourced players like IRT (IWR/IVR) systems. Veracity Logic founder Steve Zimmerman led a panel of colleagues in discussion of this subject at the CBI IRT conference in Philadelphia in 2015.

Customizing Subject Unblinding …

Case Studies

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 be entered before the unblinding can be completed. And of all of this must be accomplished quickly and efficiently.

Your current IRT’s standard system allows none of these options, and the study startup clock is ticking! What to do?
Solution:

Veracity Logic’s IRT platform is designed to maximize configurability and minimize complex coding requirements for a variety of custom setups such as the ones described above. These custom unblinding modifications can be accomplished with no additional impact on project development timelines and no loss of efficiency, saving precious time, when an emergency unblind needs to occur during the study. Authorization codes are held within the IRT system; available codes are easily accessed by the designated decision makers. A code documenting permission to register the subject is provided to the Site for entry into the IRT database. The fact that an unblinding has occurred can be easily tracked by Biostatisticians. In addition, for each study, clients can specify the list of users who will receive notification of each unblinding occurrence. The content of that notification is also readily configurable for study needs.