What's included

What goes into each interim look

  • Interim datasets and derivations built against the locked specifications for that look
  • Interim TLF programming, scoped and timed to the DMC/DSMB or ad hoc request
  • Independent QC on every interim dataset and output before release
  • Turnaround aligned to the DMC charter's review timeline

Built for the interim, not a rerun of final

Programs are scoped to exactly what the interim or ad hoc request calls for, so turnaround stays fast without cutting QC.

Same programmers, same standards

Interim datasets and TLFs are built by the same team responsible for SDTM/ADaM dataset QC, so nothing drifts from the study's ongoing conduct-phase work.