Independent by design
Programming for the DMC package is kept independent of the study team's ongoing work, protecting the blind while still moving on the charter's schedule.
What's included
What goes into each DSMB/DMC package
- DSMB/DMC dataset programming, built and QC'd independent of the study team
- Safety and efficacy outputs produced to the charter's specified formats
- Independent double programming on every output before release to the DMC
- Delivery coordinated to the DMC's review timeline
Charter-driven, not improvised
Every output format and dataset scope traces back to the DMC charter — nothing built ad hoc under deadline pressure.