TraceScribeeTMF DIA TMF Reference Model v3.3

Trial Master File Inspection readiness

Recreation of an electronic Trial Master File: the inspection-ready repository of GCP essential documents (ICH E6), organized by the DIA TMF Reference Model (11 zones, zone.section.artifact). It tracks completeness (present vs expected), timeliness (filed within 5 business days), quality (QC), and a composite inspection-readiness status gated by missing critical documents. Synthetic study; zone names and the verified artifact IDs are the real Reference Model; every figure is computed from the document list.