How do you know if your TMF is complete? How do you know if the documents have been filed in a timely manner, or at the last minute?
In order to answer these questions, you need metrics. Tracking metrics is the first step in improving both the control you have over your TMF and the processes that underpin your TMF management. Many metrics can be applied to an eTMF based on different objectives, which is why it becomes necessary to define a metrics roadmap that helps you to understand gaps and develop the most effective strategy to achieve inspection readiness. With a TMF metrics roadmap, you can foster better alignment between TMF stakeholders, giving them a clear and measurable view of the outcomes of your efforts.
In this session, we’ll cover:
- How to figure out which metrics to track
- How to develop a metrics roadmap
- Using metrics to improve decision-making and communication
- Leveraging metrics to improve your TMF process
Негізгі бет TMF Maturity Day - Session 4: Developing a Trial Master File Metrics Roadmap
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