Summary
Currently R4SUB ingests evidence from Define-XML, Pinnacle 21, and custom sources. Regulatory submissions also include Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewer's Guide (SDRG) which contain valuable readiness signals.
Tasks
Context
This is exploratory — assess feasibility before committing to implementation. ADRG is less structured than Define-XML so extraction may be unreliable.
Summary
Currently R4SUB ingests evidence from Define-XML, Pinnacle 21, and custom sources. Regulatory submissions also include Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewer's Guide (SDRG) which contain valuable readiness signals.
Tasks
adrg_to_evidence()function (or determine if out of scope)Context
This is exploratory — assess feasibility before committing to implementation. ADRG is less structured than Define-XML so extraction may be unreliable.