Overview of Viedoc TMF

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  • Published by Viedoc System 2025-04-24
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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:

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

Overview

Viedoc TMF is a digital repository for capturing, managing, sharing, and storing essential documents (records) for your clinical trial.

Viedoc TMF is based on the TMF Reference Model by the Clinical Data Interchange Standards Consortium (CDISC). The TMF Reference Model is an industry consensus catalog of all TMF records. Using the TMF Reference Model ensures compatibility and interoperability with other clinical trial parties, such as CROs.

The TMF Reference Model includes records in all different phases of a clinical trial:

  • Before the start of the trial
  • During the trial
  • After study termination

The TMF Reference Model categorizes records in zones, sections, and artifacts in a hierarchical structure:

The set of zones, sections, and artifacts included is defined in a template file that is maintained by the eTMF Manager.

The TMF can include both the Investigator Site File (ISF) and the sponsor TMF.

For portability reasons, the TMF Reference Model is defined in an Excel file.

Viedoc TMF also uses Excel files as templates for the TMF structure.

Roles and permissions

For detailed information please see Roles and permissions in Viedoc TMF.

Record statuses and actions

The following image shows the record version statuses and the actions that change the status of a record version. The initial status of a record when it is uploaded to Viedoc TMF is Unpublished.

If you edit the metadata for a record version that is Unpublished or Awaiting review, the record version status is not changed.

It is not possible to edit the metadata of a Finalized record. To make changes, a new version needs to be created.

Note! Different actions require different permissions, which means that they are performed by users with different roles.

Launching Viedoc TMF

To launch Viedoc TMF for a study log in to Viedoc, select the study from the study slider, and select the eTMF icon:

Alternatively, if you have been assigned an eTMF Manager role, you can also launch Viedoc TMF by logging into Viedoc, navigating to Viedoc Admin, selecting the study, opening the eTMF settings and selecting Launch study eTMF:

Viedoc TMF views

In the left navigation menu, there are three main areas or views in Viedoc TMF:

1. Trial Master File

2. TMF Admin

3. TMF Archive

Access to these are determined by a user's role and permissions. They are described briefly in the sections below.

Trial Master File

Users with a Viedoc Clinic role that is mapped to a TMF role have access to the Trial Master File area. In the left navigation menu, select to expand Trial Master File to see the four pages for managing records in the TMF:

The Overview page

Shows metrics for artifacts and records in the TMF. Allows the user to filter the metrics by level, site, and milestones.
The Drop Zone page

Allows users to upload or "drop" files to a public or private folder (called a "drop zone") and move them into the TMF structure later.

Please see TMF Drop Zone for more information.
The Structure page

Allows users to manage records in the TMF structure.

Please see Managing records for more information.
The Records page

Provides an table containing the records that you have access to with their metadata.

Please see TMF Records page for more information.

TMF Admin

A user with an eTMF Manager role or the Read-only eTMF Admin permission, has access to TMF Admin. In the left navigation menu, select to expand TMF Admin to see the four pages for managing the TMF:

The TMF structure page

The eTMF Manager can manage the TMF structure on this page.

Please see Editing a structure for more information.
The Templates page

The eTMF Manager can manage, import and export TMF templates on this page.

Please see the TMF Admin User Guide to find several lessons about templates.
The Settings page

Contains settings for Viedoc TMF.

Please see TMF settings for more information.
The Status page

Shows the status of the TMF, which can be one of the following:

  • Enabled: The TMF is enabled but no structure is instantiated yet.
  • Instantiated: The TMF is enabled and there is an instantiated structure. Users who have access to the TMF can work according to their roles and permissions.
  • Locked: The TMF is locked and available for users in read-only mode. Users with permissions to TMF Archive can generate and download the eTMF-EMS repository and the complete audit trail report.

TMF Archive

A user with permission to Download audit trail report have access to TMF Archive. In the left navigation menu, select to expand TMF Archive to see the two pages for generating archive reports:

The Audit Trail Report page

Allows users to generate and download a complete audit trail report.
The eTMF-EMS Repository page

Allows users to generate the eTMF - EMS Repository.

Please see TMF Archive for more information.

Viedoc Learning links

In the left navigation menu below the TMF views, users can find links to relevant user guides based on their roles and permissions including:

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