The Egnyte eTMF (Electronic Trial Master File) app lets you manage the 12 milestones in a clinical trial (defined by the Reference Model), at each filing level, and configure artifacts and documents associated with them.
1. Click Milestone Management from the eTMF home screen to bring up the milestones screen for your study:
2. Select the filing level (trial, country or site) you want to manage.
Make sure to activate the filing level first prior to managing the milestones associated with it.
Not all 12 milestones are required for each filing level.
Note in the above example, milestone 2 and 8 are missing at site SEA001. This is pre-defined by the DIS Reference Model, for each filing level.
3. Activate the milestone by selecting 'Activate' next to the milestone name on the top right side of the screen. The system will automatically register the milestone activation date in the Activation Date field. Next, if you enter a clinical trial event date for the milestone in the Clinical Trial Event Date field, the system will automatically generate a Document Filing Deadline date.