Join today (TTC KW Clinical Data Management A05)
The Clinical Data Management Close-out Process
Anders Mortin
TriTiCon consultant
In this course, will focus on the clinical data management close-out stage. We will explore how to ensure that data processing is completed, as well as the concept of a "clean file." We will discuss key topics such as database lock, trial unblinding, and the data and documentation that are delivered downstream in the process. Additionally, we will cover the archiving of data and documents, system decommissioning and timelines for this stage.
First, we will explore the essential steps to ensure that data processing is complete, and that the data can be deemed clean. Here will cover the clean file meeting, handling of residual issues within the data, and how we assess protocol deviations.
Then will concentrate on database lock and trial unblinding data delivery. We will also discuss the concepts of interim and partial database locks.
Finally , we will focus on the final archiving of data and documents, as well as the decommissioning of data collection and handling systems.
We will conclude with a discussion on typical and achievable timelines for these activities.
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