Checklist for optimal practical arrangements for interim
analysis and data monitoring.
- Set up first organisational meeting to review the protocol,
establish procedure and agree terms of reference before starting
enrollment or before the first interim analysis.
- The frequency of meetings may be reviewed on the basis of
how quickly information accumulates on the primary outcomes.
- Earlier meetings should focus on monitoring safety and
trial conduct because efficacy information accumulates at a slower rate
earlier in a trial.
- Setting up the meetings is the responsibility of the
sponsor or the coordinating center with input from the DMC.
- Some meetings can be by correspondence or teleconference
but when
the data is complex or the trial is at a crucial stage a face to face
meeting is necessary.
Back
to scheduling and organising the DMC meetings
This page was last updated September 2008.