There are three roles in the Egnyte eTMF (Electronic Trial Master File) app:
- eTMF Administrator
- Study Manager
- Filing Level Manager
The Egnyte Domain Administrator has all the administrative rights for the eTMF app. A role created for a Power User with the “Can manage eTMF” capability enabled is referred to as eTMF Administrator.
These users need the “can run reports” capability enabled to access audit reports.
Both the Egnyte Domain Administrator and eTMF Administrator can create and manage eTMF. They can set the role-based permissions at the filing levels by adding user groups to Study Manager, Filing Level Manager roles. They can upload/delete documents, manage milestones, and configure artifacts for a study.
The Study Manager is the user belonging to a group added as a Study Manager role for the study. The Study Managers can access and manage all filing levels they are given access to by an Administrator.
The Filing Level Manager is the user belonging to a group added as a Filing Level role for the specific countries and sites in a study. The Filing Level Managers can only access and manage documents, artifacts and milestones at their own filing levels i.e. in the above screen, A Filing Level Manager for the USA country level cannot access the CAN (Canada) filing level and vice versa.
Both Power and Standard User types can be added to the groups for Study Manager and Filing Level Manager roles.
The table below lists the capabilities of the three roles in the eTMF app:
|
Capability |
Filing Level Manager |
Study Manager |
Admin / eTMF App Admin |
| Add New Study | X | ✔ | ✔ |
| Study Details | X | ✔ | ✔ |
| Artifact Configuration | ✔ | ✔ | ✔ |
| Add Filing Level Details | ✔ | ✔ | ✔ |
| Filing Level Permissions Setup | X | ✔ | ✔ |
| Manage Filing Level Milestones | X | ✔ | ✔ |
| Access Filing Level Dashboard | ✔ | ✔ | ✔ |
| Filing Level Upload | ✔ | ✔ | ✔ |
| Filing Level Reporting | ✔ | ✔ | ✔ |
| Filing Level File System Access | ✔ | ✔ | ✔ |
| Milestone Activation/Deactivation | ✔ | ✔ | ✔ |
| Study Level Activation/Deactivation | X | ✔ | ✔ |
| Artifact Deletion | ✔ | ✔ | ✔ |
| Artifact Addition | ✔ | ✔ | ✔ |
| Filing Level Viewer/File Preview | ✔ | ✔ | ✔ |
| Import/Export | X | X | ✔ |