⚠The deterministic checks are the validated backbone — pre-specified thresholds; a flag is a screening prompt, the medical monitor / SRC / covering biostatistician decide; reported numbers (incidence tables, the ICH E14 table, central reads, MTD, final disposition) come only from validated tools (Phoenix WinNonlin / Pinnacle 21), never this dashboard. Data is synthetic and illustrative — no real participants, no PHI, no treatment unblinding. Thresholds/SLAs/windows shown are illustrative; the live version reads protocol/SAP limits.