Independent from day one
The firewall and reporting structure are established in the DMC charter before the first report is ever produced.
What's included
What goes into DMC/DSMB reporting
- Unblinded safety and efficacy summaries produced against the analysis plan defined in the DMC charter
- Report production performed by statisticians with no other role on the study, per the charter's access controls
- Tables, listings, and figures prepared for each scheduled DMC/DSMB meeting, plus ad hoc reports when triggered by stopping rules
- Open and closed session materials kept separate, with distribution limited to the appropriate audience
- Meeting minutes and recommendations tracked and archived alongside the report package
Consistent with interim analysis
Reports draw on the same independently produced results as the study's interim analysis, so the committee sees one consistent, defensible number set.
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