Maintaining Compliance with New ICH Monitoring Guidelines
The latest revised ICH E6 R2 guidelines has prompted the need for sponsors to be empowered to create their own audit trail reports within Interactive Response Technology (IRT) systems. This case study reveals how one sponsor company was given an easier, more efficient way for the study team to monitor data on the chain of custody for drugs and on drug assignments.
You will learn:
- What inspectors want to see from sponsors
- How to obtain on-demand reporting capabilities
- How to remain inspection-ready at all times
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