Summary
Current traceability handles direct ADaM → SDTM mappings. Real submissions often have multi-step chains: SDTM → intermediate ADaM → final ADaM (e.g., ADSL → ADAE derivations).
Tasks
Why
Complex submissions (oncology, rare diseases) have deeply nested derivation chains. Shallow tracing underestimates actual traceability coverage.
Summary
Current traceability handles direct ADaM → SDTM mappings. Real submissions often have multi-step chains: SDTM → intermediate ADaM → final ADaM (e.g., ADSL → ADAE derivations).
Tasks
trace_depthparameter to control maximum chain lengthWhy
Complex submissions (oncology, rare diseases) have deeply nested derivation chains. Shallow tracing underestimates actual traceability coverage.