One team, no handoffs
The same biostatistics and programming team that finalized the TLF shells executes production, so nothing gets reinterpreted in the transfer.
What's included
What goes into production
- Production programming for every TLF in the finalized shell package, run against the locked database
- Independent double programming and QC on primary and key secondary efficacy and safety outputs
- Traceability from each output back to its SAP method and CDISC-aligned analysis dataset
- Discrepancy resolution logged and closed out before outputs are released for review
- A finalized TLF package handed to medical writing to support statistical input to the CSR
Confirmed again after lock
Outputs produced here are re-run and reconfirmed during post-DBL TLF finalization against the final locked dataset.