Blinded by design
Review stays within the blinded team, kept separate from the unblinded work behind DMC/DSMB reporting.
What's included
What goes into statistical data review
- Blinded listings reviewed on the cadence and criteria set out in the Data Review Plan
- Trend, outlier, and plausibility checks focused on fields feeding key efficacy and safety endpoints
- Findings routed back to data management and clinical for query resolution, with issues tracked to closure
- Recurring issues escalated for edit check or process changes rather than repeated manual review
- Review status summarized ahead of each internal data review meeting
Feeds cross-functional review
Findings inform the broader blinded data review meeting, alongside clinical and data management perspectives.