Case Study: No Wi-Fi? How a Native App Provides Randomization Solutions

Registration and Randomization using a native app with local storage of data

IVRCC’s custom-built native app was an ideal choice for the Operating Room that had no access to Wi-Fi, by being able to accommodate a large number of Inclusion/Exclusion criteria, the possibility of tablet or internet failure, and proper randomization treatment assignment exactly per protocol.

Objective

  • To provide near real-time per-protocol randomization assignments within hospital No Wi-Fi zones.

Highlights

  • IVRCC Native App - Subject Randomization for Clinical TrialsIVRCC’s Native App solution solved the problem of randomization in a No Wi-Fi zone Hospital Operating Room (OR), where timeline to treatment was very short.
  • The IVRCC native app provided local storage on each site’s device until it was possible to upload data.
  • Study personnel were required to answer a large number of detailed Inclusion/Exclusion questions using multiple choice checkboxes, number entry, and drop-down choices, which precluded the use of a voice phone call Interactive Voice Response System (IVRS).
  • If the tablet was lost, or when internet access was not available even outside of the OR, unique Randomization Locking mechanisms prevented duplicate randomization code assignments and allowed for the rare circumstance of paper randomization back-up.
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