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Monitoring without SDV or Regulatory Document Collection: The Monitor's Critical Role and How it Has Changed

Time

Tue, Jun 25 11:45AM
T 24

Title

Monitoring without SDV or Regulatory Document Collection: The Monitor's Critical Role and How it Has Changed

Abstract Summary

We implemented a combination of electronic systems to collect Source Data directly, review informed consents remotely, and manage all site regulatory documents electronically. The Monitors for this study had very different responsibilities than they have in a traditional trial. This poster will demonstrate the changes in monitor's responsibilities, staffing, and training using this Risk-Based Monitoring approach.

Poster Presenter

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

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