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Implementing a Standard Report Set for Risk Based Monitoring Domains

Time

Wed, Jun 18 7:15AM
W 25

Title

Implementing a Standard Report Set for Risk Based Monitoring Domains

Abstract Summary

We identified 11 domains that are needed in each trial for Risk Based Monitoring. Additional domains that are related to the primary efficacy endpoint are designed specifically for a trial or program. We developed a set of reports that provide data for each domain.

Poster Presenter

Christine Riley-Wagenmann
Manager,
NextGen Clinical Data Solutions
United States