A new industry schema proposal targets a recurring clinical-trial operations problem: duplicated or fragmented subject identifiers across CRO and sponsor portfolios. The authors describe a standardized site- and program-aware subject ID convention intended to improve traceability, rescreening continuity, and alignment with FDA and CDISC data submission expectations. The framework addresses operational failure modes where study-specific identifier conventions make it hard to track participants moving into extensions or rolling studies, potentially undermining data quality and regulatory review efficiency. The schema encodes site number, program identifier, phase number, sequencing details, and a screening/rescreening identifier. For sponsors coordinating multiple vendors, the change is positioned as a practical step to reduce duplication risk and improve end-to-end auditability as trial complexity increases.
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