Independence is the point
The QC programmer works from the same specification as production, never from the production code itself, so agreement means the logic is actually correct.
What's included
What goes into independent QC
- A separate programmer builds each dataset or TLF program directly from the specification, without access to the production code
- Outputs compared line by line, with every discrepancy logged and resolved before sign-off
- Coverage extended across SDTM, ADaM, and TLF programs according to the study's risk-based QC plan
- Discrepancy resolution documented so reviewers can see how differences were investigated and closed
- QC evidence retained as part of the audit trail supporting inspection readiness
- Re-verification triggered whenever a spec or protocol amendment changes the underlying logic
Carries through the study, not just once
The same independent QC discipline continues into conduct as SDTM/ADaM Dataset QC on each accruing data cut.