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.
Uploading Documents to Your eTMF
1. To upload documents to active filing levels and milestones, go to the study 'Dashboard' from the home screen. All active filing levels and milestones and their associated artifacts are displayed on this screen.
2. There are two ways to upload documents to required artifacts:
Click 'Upload' to navigate to the artifact where you want to upload the document(s) to:
Under 'List of Artifacts,' when scrolling through the list to select the artifact you want to upload document(s)to, the system will display an 'Upload' button next to the artifact name. Click the button and upload document(s) directly into that artifact.
3. As documents are uploaded throughout your study, the document filing completion status is tracted in the 'Completeness Report' section of the 'Dashboard.'