Regulatory watch · 12 Nov 2025
What ICH GCP E6(R3) actually changes for programmers
R3 is not a new TLF list. It is a quality-by-design expectation that reaches the programs, the QC, and the way we document decisions.
ICH E6(R3) asks sponsors to design quality in, not inspect it in at the end. For statistical programmers and data managers, that is less about a new template and more about whether the audit trail, the QC plan, and the critical-to-quality factors are visible in the work we already do.
The practical shift: risk-based thinking in the SAP and the programming plan. If a display is not critical to a decision, it should not consume the same QC as a primary endpoint. If it is critical, double programming is not optional colour.
CodLad’s response has been to write a short programming quality plan for every study we take — what is double-programmed, what is independently reviewed, what is spot-checked — and to keep that plan with the delivery pack. It is the document an inspector can follow without a guided tour.
If you are updating SOPs for R3, start with critical-to-quality factors that a programmer can actually act on. A principle that cannot be coded is a poster.
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