Errors (1)
USDM-REQ-003
At least one endpoint is required.
path: endpoint
suggestion: Extract primary endpoint(s) from objectives/endpoints section.
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Validate Run cmo6em69
Business view: validation turns reviewed fields into a trustable package by checking structural completeness and cross-section consistency.
Validation Report
status: fail
Warnings (3)
USDM-REQ-002
No treatment arms found.
path: studyDesign.arms
suggestion: Capture at least one treatment arm from design section.
TEMPLATE-001
Objectives section appears missing.
path: study.objective
suggestion: Extract objective section to improve protocol completeness.
TEMPLATE-002
Safety monitoring section is missing.
path: study.safetyMonitoring
suggestion: Map safety monitoring statements from protocol.