A REDCap advanced randomization module to meet the needs of modern trials.

OBJECTIVE: Since 2012, the electronic data capture platform REDCap has included an embedded randomization module allowing a single randomization per study record with the ability to stratify by variables such as study site and participant sex at birth. In recent years, platform, adaptive, decentralized, and pragmatic trials have gained popularity. These trial designs often require approaches to randomization not supported by the original REDCap randomization module, including randomizing patients into multiple domains or at multiple points in time, changing allocation tables to add or drop study groups, or adaptively changing allocation ratios based on data from previously enrolled participants. Our team aimed to develop new randomization functions to address these issues. METHODS: A collaborative process facilitated by the NIH-funded Trial Innovation Network was initiated to modernize the randomization module in REDCap, incorporating feedback from clinical trialists, biostatisticians, technologists, and other experts. RESULTS: This effort led to the development of an advanced randomization module within the REDCap platform. In addition to supporting platform, adaptive, decentralized, and pragmatic trials, the new module introduces several new features, such as improved support for blinded randomization, additional randomization metadata capture (e.g., user identity and timestamp), additional tools allowing REDCap administrators to support investigators using the randomization module, and the ability for clinicians participating in pragmatic or decentralized trials to perform randomization through a survey without needing log-in access to the study database. As of June 19, 2025, multiple randomizations have been used in 211 projects from 55 institutions, randomizations with real-time trigger logic in 108 projects from 64 institutions, and blinded group allocation in 24 projects from 17 institutions. CONCLUSION: The new randomization module aims to streamline the randomization process, improve trial efficiency, and ensure robust data integrity, thereby supporting the conduct of more sophisticated and adaptive clinical trials.

Duke Scholars

Author Christopher Lindsell Biostatistics & Bioinformatics, Division of Biostatistics