Egnyte Domain Administrators and Power Users with a role that includes managing the eTMF App are collectively referred to as eTMF Administrators.  eTMF Administrators have access to create and manage studies.  eTMF Administrators can assign one or more existing Egnyte groups to manage an individual study. Users in these groups and eTMF Administrators are known as Study Managers. Study Managers have the ability to view and edit study configuration, manage filing levels, manage milestones, upload files, and run reports.

Study Managers' Permissions 

At each filing level, permissions can be set to control which users can manage that filing level (Filing Level Managers), upload documents for that filing level (Filing Level Uploaders), and view documents for that filing level (Filing Level Viewers).



Filing Level Manager

Manage filing level configuration
Manage filing level permissions
Manage filing level milestones
View filing level dashboard
Upload filing level documents
View filing level documents
View filing level completeness report

Filing Level Uploader

View filing level dashboard
Upload filing level documents
View filing level documents

Filing Level Viewer

View filing level dashboard
View filing level documents


Additional Notes:

  • Study Managers and Filing Level Managers can set filing level permissions by associating existing Egnyte groups with a given filing level permission.
  • Filing level permissions are inherited to lower levels in the study hierarchy, i.e., from the trial to all countries and from a country to its sites.
  • A filing level permission set for a group at one level cannot be removed at a lower level in the study hierarchy.
  • If a user has been assigned to multiple permissions at a given filing level, the greater permission will apply.  For example, if a user’s group membership grants them both File Level Uploader and Filing Level Viewer permissions at a given level, the Filing Level Uploader permission will apply.
  • Study Managers implicitly are granted Filing Level Manager permissions for all filing levels in the study.