TraceScribeRTSM / IRT GAMP 5 · 21 CFR 11

Randomization & Trial Supply IRT

Recreation of a Randomization and Trial Supply Management (RTSM / IRT) system: a stratified permuted-block randomization built from a randomization plan, real-time treatment allocation that preserves the blind (toggle the view), and depot-to-site drug supply with par-level + predictive resupply, expiry, and cold-chain handling. Synthetic study; every figure is computed from the randomization list and inventory.