Samples / OBX-319 / regulatory/m5-clinical/define/ARM-301_analysis_results_metadata.md

Analysis Results Metadata (OBX319-301)

Document ID: ARM-301
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC ARM

Analysis Results Metadata (ARM) — OBX319-301

Results-level metadata for OBX319-301: for each key analysis (primary, key secondary, safety), the analysis parameters, dataset and rows, method, and the traceability to the ADaM datasets and the TFL outputs. CDISC Analysis Results Metadata; Define-XML 2.1.