There are seven roles in the Egnyte eTMF (Electronic Trial Master File) app:
- eTMF Administrator
- Study Manager
- Filing Level Manager
- Filing Level Uploader
- Filing Level Viewer
- Filing Level Approver
- Filing Level Unblinded Access (Limited Availability)
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 that is 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 that is 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 Viewer can only view documents at their own filing levels that is 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.
Filing Level Unblinded Access (Limited Availability)
Users gain Filing Level Unblinded Access when they belong to a group assigned the Unblinded Access permission at a given filing level (trial, country, and/or site). The permission applies to the filing level at which it is applied, and to all of its child filing levels (such as, all sites below a country).
A user with Filing Level Unblinded Access may view and edit unblinded documents (documents classified to an artifact with a blinding value of “unblinded”) when assigned the Filing Level Unblinded Access role in addition to their other permissions, such as in the following example:
- User one is assigned the role of Filing Level Viewer, and can see documents at that filing level which are assigned to artifacts with a blinding value of “blinded.”
- User two is assigned the roles of Filing Level Viewer and Filing Level Unblinded Access, and can see documents at that filing level which are assigned to artifacts with a blinding value of “blinded” and documents at that filing level which are assigned to artifacts with a blinding value of “unblinded.”
The table below lists the capabilities of the seven roles in the eTMF app:
| Capability | Filing Level Viewer | Filing Level Uploader | Filing Level Manager | Filing Level Approver |
Filing Level Unblinded Access (Limited Availability) |
Study Manager | Admin / eTMF App Admin |
| Add New Study | X | X | X | X | X | ✔ | ✔ |
| Study Details | X | X | X | X | X | ✔ | ✔ |
| Artifact Configuration | X | X | ✔ | X | X | ✔ | ✔ |
| Add Filing Level Details | X | X | ✔ | X | X | ✔ | ✔ |
| Filing Level Permissions Setup | X | X | X | X | X | ✔ | ✔ |
| Manage Filing Level Milestones | X | X | X | X | X | ✔ | ✔ |
| Access Filing Level Dashboard | ✔ | ✔ | ✔ | ✔ | X | ✔ | ✔ |
| Filing Level Upload | X | ✔ | ✔ | X | X | ✔ | ✔ |
| Filing Level Reporting | X | X | ✔ | X | X | ✔ | ✔ |
| Filing Level File System Access | ✔ | ✔ | ✔ | ✔ | X | ✔ | ✔ |
| Milestone Activation/Deactivation | X | X | ✔ | X | X | ✔ | ✔ |
| Study Level Activation/Deactivation | X | X | X | X | X | ✔ | ✔ |
| Artifact Deletion | X | X | ✔ | X | X | ✔ | ✔ |
| Artifact Addition | X | X | ✔ | X | X | ✔ | ✔ |
| Filing Level Viewer/File Preview | ✔ | ✔ | ✔ | ✔ | X | ✔ | ✔ |
| Import TMF | X | X | X | X | X | ✔ | ✔ |
| Initiate QC | X | ✔ | ✔ | X | X | ✔ | ✔ |
| Reject & Approve Documents | X | X | X | ✔ | X | X | X |
| View & Add QC Comments | X | ✔ | ✔ | ✔ | X | ✔ | ✔ |
| Enable/Disable Auto-Approve | X | X | X | X | X | ✔ | ✔ |
| Access to Filing Level Staging Content | X | ✔ | ✔ | Read Only | X | ✔ | ✔ |
| Access to Filing Level Approved Content | Read Only | Read Only | Read Only | Read Only | X | Read Only | ✔ |
| Access eTMF Settings Page | X | X | X | X | X | X | ✔ |
| View Unblinded Content (when paired with a permission which grants view access) | X | X | X | X | ✔ | X | X |
| Edit Unblinded Content (when paired with a permission which grants edit access) | X | X | X | X | ✔ | X | X |