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Milestones

Milestones are significant events or phases within the lifecycle of a clinical trial that require documentation and tracking. Milestones are configured according to the study plan and protocol, representing key stages of the clinical trial process, such as study initiation, site training, patient enrollment completion, and many others. They are critical for planning, monitoring, and managing the trial progress effectively.

Each milestone is typically associated with specific documentation or files that need to be completed, approved, and filed in the TMF. This ensures that all relevant materials are organized and accessible, which eventually helps teams to track the progress of the trial relative to its timeline and objectives, providing insights into whether the study is on schedule or if adjustments are needed.

In eTMF, the Milestone tab of the Study Tracking page displays the list of study milestones. There are two ways of milestone origination in eTMF:

Milestone list
Figure 1. Milestone list

You can perform the following actions with the milestones:

In this section:

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.