Programs built against a spec, not a memory
Programmers code directly from the spec, keeping every table, listing, and figure consistent with what the SAP defines.
What's included
What goes into the TLF specs
- Every mock shell from the SAP expanded into a program spec naming the exact ADaM source, population, and subgroup
- Statistical methods and footnote logic documented so programming choices match the SAP without reinterpretation
- Titles, footnotes, and formatting conventions standardized across the full TLF set
- Numbering and cross-referencing aligned to the table of contents sponsors will review against
- Sign-off from biostatistics before programming starts, so specs don't drift from analysis intent
- Living updates as interim analyses or SAP amendments add or revise shells
One set of specs, reused through conduct and close out
The same specs drive Final TLF Production and any interim programming requested along the way.