Deterministic Integrity Gates for LLM-Assisted Clinical Manuscript Preparation: An Auditable Biomedical Informatics Architecture
Current large language model (LLM)-generated clinical research manuscripts commonly suffer from fabricated citations, data drift, and omissions of reporting guidelines, yet existing tools lack effective validation mechanisms. This work proposes an integrated generation-and-verification architecture that decomposes the writing process into 43 skill modules—including 21 deterministic detectors—orchestrated by a unified coordinator. It introduces a “maximally deterministic” completeness gating mechanism to enforce structured, traceable audits and re-execution checks at each stage. Evaluated on the STARD, PRISMA, and STROBE benchmark datasets, the approach successfully identified all 27 injected defects with zero false positives, substantially outperforming general-purpose LLM-based review methods.