No handoff between programming and the report
The same team that ran final TLF production supports the CSR draft cycle, so questions about a number get answered by the person who programmed it.
What's included
Keeping CSR tables and figures aligned with final programming output
- Final TLFs reformatted and renumbered to match the CSR's table of contents and body text references
- Programming support through each CSR draft cycle as medical writing requests reruns, re-cuts, or additional footnotes
- Cross-checks between in-text CSR figures and the underlying programmed output to catch transcription errors
- Version tracking so every CSR draft references a documented, reproducible TLF version
- Final reconciliation pass before the CSR is submitted for QC sign-off
Locked once outputs are locked
Once tables and figures pass post-DBL dataset and TLF lock, CSR support becomes reconciliation, not rework.