Researchers described a portfolio-wide standardized clinical trial subject ID schema designed to solve CRO and sponsor tracking problems caused by study-specific identifier conventions. The paper argues that duplicative or fragmented subject IDs across trials can complicate rescreening continuity, extension-study tracking, and regulatory review. The proposed framework incorporates multiple components—such as site number, program identifier, study phase number, and screening/rescreening identifiers—expressed as SSSS-PYZ-XXXA. The authors say the design aligns with FDA and CDISC expectations to support international submissions and improve traceability of subjects across complex portfolios. The publication positions the schema as an operational and compliance upgrade for companies running multi-trial programs with multiple CRO vendors. If broadly adopted, it could reduce downstream data reconciliation costs and lower the risk of delays during regulator-facing review cycles.
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