Audit Trail Integrity in Remote and Decentralized Trials
Decentralized Clinical Trials (DCTs) and hybrid models have revolutionized how sponsors collect data, engage participants, and reduce site burden. However, with these advances come significant challenges in managing and securing audit trails—especially as data flows through mobile apps, wearables, ePRO/eCOA platforms, and cloud-based systems across geographically dispersed environments.
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