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.
- IVRCC’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.
- To provide near real-time per-protocol randomization assignments within hospital No Wi-Fi zones.
- Pivotal 5-year study, with 250 subjects at ~30 European and US sites.
- Efficacy based on the change from baseline to 24 months in the average overall KOOS score (Pain, Symptoms, QOL, and others)
- Error-free and rapid real-time randomization in OR’s where Wi-Fi service is restricted, for immediate assignment of treatment for imminent surgical procedures
IVRCC Solutions to Meet Challenges
- The study utilized one model of dedicated 7″ Android tablets, with one main tablet in use per site.
- Back-up tablets were made available for quick replacement if needed.
- An automated update notification appeared as an on-screen pop-up when a newer version of the app was deployed.
- The native app was available for download only by specific authorized users to specified tablets from a secure IVRCC website.
- The native app provided the ability to randomize in any Operating Room No Wi-Fi zone. When access to internet became available, data was uploaded to servers and was transferred to the final EDC database.
- Locking mechanisms were installed to prevent re-use of randomization codes and allowed for an emergency paper randomization back-up process if needed.
- A user manual, training sessions, detailed guidance, and confirmation steps throughout the app, with email, SMS and screen pop-up notifications, were utilized to ensure informed use of the system.
- Viewable reports showed the latest status information about each site’s subjects.
- IVRCC’s secure website was used to download the Android application to provision-specific tablets for the screening and randomization process, view reports and access various lock, and recovery tasks.
- Study personnel users were permitted access to the applications per Client authorization, based on specific roles and permissions.
- A dedicated tablet was utilized during the surgical procedure, where screening data was entered and randomization was assigned immediately prior to surgery.
- Subjects were created in the EDC system, transferred to the tablet, and locked for the offline screening/randomization process.
- Screen failures or eligibility to randomize were automatically determined based on study coordinators’ screening data entries to the native off-line tablet app, while in the “no Wi-Fi” Operating Room environments.
- After randomization arm was revealed, the site could choose to screen another available subject or go back online, to upload data, and unlock randomization.
- Upon connection to internet via Wi-Fi outside of the OR, data collected during screening and randomization was electronically authenticated, uploaded, and transferred to EDC, and unlocked for next subject randomization.
- Pop-up notifications, email notifications and SMS text messages were deployed at event-triggered times to ensure that site users were aware of current processes occurring at their sites.
- The randomization process also utilized an “emergency” back-up paper process in the rare event that internet access or tablet would not be available within an adequate period of time. These paper randomization activities conformed to detailed procedures, to insure proper execution and subsequent audit trail documentation of the randomization protocol.
Why was IVRCC the right choice for this study?
- The planned build timelines were met for rapid deployment of the trial.
- Commercially-available, cost-effective tablets were chosen and were restricted to the native app designed for the study.
- IVRCC’s vast clinical trial experience and technological expertise enhanced the build process with creative mechanisms for locking, unlocking, and recovery. IVRCC and client pre-empted many possible problem scenarios, which included tablet loss or failure, unavailable server access, and widespread internet access failure.
- IVRCC worked closely with the client and proposed a series of detailed instructions and confirmation steps to ensure that subjects received correct treatment assignment according to the randomization tables, and were able to randomize using paper envelope back-up when circumstances prevented tablet use.
- IVRCC and the client were flexible when considering digital/paper solution combinations to solve complex randomization needs.
- No subjects were precluded from the screening-randomization process due to server or internet access issues.