There are five roles in the Egnyte eTMF (Electronic Trial Master File) app:
- eTMF Administrator
- Study Manager
- Filing Level Manager
- Filing Level Uploader
- Filing Level Viewer
eTMF Administrator
A role created for a Power User with the “Can manage eTMF” capability enabled is referred to as eTMF Administrator. The Egnyte Domain Administrator also has all the administrative rights for the eTMF app.
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 a study within eTMF. They can set the role-based permissions at the filing levels by adding user groups to Study Manager, Filing Level Manager, Filing Level Uploader, and Filing Level Viewer roles. They can also upload/delete documents, manage milestones, and configure artifacts for a study.
Study Manager
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.
Filing Level Manager
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.
Filing Level Uploader
The Filing Level Uploader is the user belonging to a group selected for “Who can add documents to this level?” for specific countries and/or sites in a study. The Filing Level Uploader can only upload documents at their own filing levels i.e. in the above screen, A Filing Level Uploader for the USA country level cannot upload documents at the CAN (Canada) filing level and vice versa.
Filing Level Viewer
The Filing Level Viewer is the user belonging to a group selected for “Who can view documents in this level?” for specific countries and/or sites in a study. The Filing Level Uploader can only view documents at their own filing levels i.e. in the above screen, A Filing Level Viewer for the USA country level cannot upload documents at the CAN (Canada) filing level and vice versa.
The table below lists the capabilities of the five roles in the eTMF app:
|
Capability |
Filing Level Viewer |
Filing Level Uploader |
Filing Level Manager |
Study Manager |
Admin / eTMF App Admin |
| Add New Study | X | X | X | ✔ | ✔ |
| Study Details | X | X | X | ✔ | ✔ |
| Artifact Configuration | X | X | ✔ | ✔ | ✔ |
| Add Filing Level Details | X | X | ✔ | ✔ | ✔ |
| Filing Level Permissions Setup | X | X | X | ✔ | ✔ |
| Manage Filing Level Milestones | X | X | X | ✔ | ✔ |
| Access Filing Level Dashboard | ✔ | ✔ | ✔ | ✔ | ✔ |
| Filing Level Upload | X | ✔ | ✔ | ✔ | ✔ |
| Filing Level Reporting | X | X | ✔ | ✔ | ✔ |
| Filing Level File System Access | ✔ | ✔ | ✔ | ✔ | ✔ |
| Milestone Activation/Deactivation | X | X | ✔ | ✔ | ✔ |
| Study Level Activation/Deactivation | X | X | X | ✔ | ✔ |
| Artifact Deletion | X | X | ✔ | ✔ | ✔ |
| Artifact Addition | X | X | ✔ | ✔ | ✔ |
| Filing Level Viewer/File Preview | ✔ | ✔ | ✔ | ✔ | ✔ |
| Import TMF | X | X | X | ✔ | ✔ |