🎯 Challenges
Managing a double-blind multi-treatment project with randomization, emergency unblinding, and medication allocation presented several challenges.
- Ensuring easy randomization.
- Maintaining double-blind conditions within the Electronic Data Capture (EDC) system.
- Allocating the correct Investigational Medicinal Product (IMP).
- Ensuring safe emergency unblinding while maintaining blindness within the EDC.
💡 Solution
To address these challenges, an inbuilt randomization, medication allocation, and emergency allocation tool within Clincase was utilized. The Clincase Clinical Supply System was employed for tracking electronic medication shipments and maintaining site IMP levels. Detailed specifications were created, reviewed, and approved by relevant stakeholders, including the Sponsor, Biostatistics, Data Management, and Clincase, followed by comprehensive testing.
The tool was linked with randomization and IMP allocation features to ensure correct randomization and IMP allocation. Expiry dates were tracked via the system to prevent the allocation of expired medication to patients.
Randomization forms were enabled only when specific criteria were met in the EDC, streamlining the process for sites. Emergency unblinding was restricted to authorized personnel, with data displayed via a pop-up to prevent unblinding information from being logged in the audit trail.
System reports were generated to facilitate fast tracking and oversight, while email notifications were enabled to alert the team of patient randomization and emergency unblinding events, without disclosing unblinding information.
🌟 Results
The implementation of randomization, IMP allocation, and emergency unblinding was successful, with all actions tracked via the system's audit trail and email alerts. The system proved to be highly user-friendly for site users, as it consolidated all necessary tools into one platform, eliminating the need for separate randomization, drug management, or emergency unblinding tools.
