Note! This page contains information and instructions for the new TMF user interface. If you are using the old interface, please go to the relevant user guides:

• Viedoc eTMF User Guide (old interface)
• Viedoc User Guide for eTMF Managers (old interface)

Want to browse more information for the new interface? Please go to the new TMF user guides:

• Viedoc TMF User Guide
• Viedoc TMF Admin User Guide

Introduction

In Viedoc TMF, roles and permissions determine what a user can or can't see in the application, which actions they can perform, and which records they can access. Proper role assignment ensures secure and efficient record management while maintaining compliance with regulatory requirements.

Viedoc system and clinic roles that can access Viedoc TMF

In Viedoc, there are two types of roles:

• System roles are predefined by Viedoc and cannot be changed, and give access to various features in Viedoc Admin and Viedoc Designer.
  • The Study Manager is the only system role that can assign the eTMF Manager role to a user in Viedoc Admin.
  • The eTMF Manager is a system role that can manage the TMF settings in Viedoc Admin, map clinic roles to TMF roles, and access the TMF admin rea in the TMF application.
• Clinic roles (sometimes called study roles or EDC roles) can be customized to each individual study. These roles give access to Viedoc Clinic.
  • The eTMF manager can map specific TMF roles and permissions to the different clinic roles, creating customized role-based access. See the Mapping roles section below for instructions on how to do this.

See About roles in Viedoc for more information about system and clinic roles in Viedoc.

TMF roles, which are different from Viedoc system and clinic roles, are described in the next section.

Viedoc TMF roles and permissions

The user access to Viedoc TMF is determined by the assigned roles and permissions. TMF roles and permissions can work in combination or independently.

TMF Levels and permissions

Depending on the permission associated with your user role, you can perform different actions on records. Your user role can have permission (no access, read, write, or review) on these TMF levels:

• Study/trial
• Country
• Site

These levels and permissions need to be explained better

You can only see and access records if you have permissions for the artifact on the corresponding TMF level.

For example, if an artifact is linked to two sites, a user with write permission for the artifact for only one of the sites will be able to read but not edit the record. This is due to the fact that the user does not have write permissions for all sites that the record is linked to.

The eTMF Manager role

The eTMF Manager is a Viedoc system role (see above) and has permissions to manage the TMF application in Viedoc Admin and to manage templates in Viedoc TMF.

The TMF user roles

The user access to Viedoc TMF is determined by the assigned roles and permissions. The roles and permissions can work in combination or independently. These user roles are defined in the template, which is maintained by the eTMF Manager.

The TMF roles are:

• Site staff
• Sponsor study
• Sponsor country
• Sponsor site
• Reviewer
• Sponsor Data Manager
• Sponsor unblinded

The respective permissions for these TMF roles are specified in the Excel template file, on the Role sheets. For more information, see the Roles sheets section in the Customizing a template lesson.

The TMF permissions

These permissions are defined in Viedoc Admin and are assigned to users by the eTMF Manager. See Assigning roles and permissions in Viedoc Admin below for instructions on how to do this.

Permissions in Viedoc TMF can work in combination with roles or independently, providing granular control over user actions:

For TMF access use cases and frequently asked questions, please see TMF access use cases.

Assigning Roles and Permissions in Viedoc Admin

Viedoc TMF user roles are assigned and managed in Viedoc Admin.

Only the eTMF Manager has permission to assign and manage TMF user roles for a specific study.

Mapping clinic roles to TMF roles and permissions

To map the Viedoc clinic roles to TMF roles and permissions:

1	Go to Viedoc Admin, and select a study to open the study overview page:
2	Select the eTMF settings button:
3	In the eTMF roles mapping area, select the TMF role(s) and/or permission(s) that you want to map to the Viedoc clinic (study) roles: Note! The Viedoc study roles correspond to the Clinic roles for the study, and are set in the study design. The TMF roles correspond to the roles specified in the TMF template file. You can map a study role to one or several TMF roles and permissions.
4	Select Save changes.

Modifying and revoking roles

• To modify a role, follow the same steps above and select a new role or permission.
• To remove a user’s access, follow the same steps above and remove the role or permission from their associated study role.

Best practices for assigning permissions

• Assign roles based on job responsibilities—avoid giving excessive permissions.
• Regularly review user roles to ensure compliance and security.
• Use custom roles when predefined options don’t meet operational needs.
• Limit eTMF Manager access to only those responsible for system-wide TMF settings.

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TMF roles, permissions and tasks

The following table lists several examples of tasks that study users can face, together with the TMF roles, the Viedoc Clinic site groups, and the TMF level access that they would need to perform the respective task.

For more information about site groups, see Managing users and Managing study sites in the Viedoc Admin User Guide.

For TMF access use cases and frequently asked questions, please see TMF access use cases.

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