Viedoc TMF

  • Published by Viedoc System 2025-04-24
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Note! The intended target group for this document is the Viedoc Sales personnel.

Introduction

This document discusses the differences and similarities between a study eTMF and an archive eTMF. It also explains the intended use of Viedoc TMF and its strengths.

Both study and archive eTMFs are important for maintaining the integrity and transparency of clinical trial activities.

Study eTMF

A study eTMF is meant to be used during the trial with real-time access for stakeholders. The system is meant to support an ongoing process that happens during the course of the clinical trial to monitor its progress.

During the trial

The use of a study eTMF is an ongoing process throughout the clinical trial. It involves regular monitoring and review of the records within the eTMF to ensure that the trial is being conducted in accordance with regulatory requirements, GCP, and the study protocol

Real-time access

Stakeholders, such as monitors, regulatory authorities, and sponsors can access the eTMF to track the progress of the trial, review documentation, and identify any issues that might need to be addressed.

Archive eTMF

An archive eTMF is used post-trial for long-term preservation. The system is meant to support the process of securely storing and preserving trial documentation for future reference, inspections, and regulatory compliance after the trial has concluded.

Post-trial

Archiving the eTMF occurs at the end of the clinical trial or when a specific phase is completed. It involves securely storing the records in a controlled and accessible manner to ensure compliance with regulatory requirements and to facilitate future inspections or audits.

Long-term preservation

Archiving ensures the long-term preservation of trial records, providing a complete and accurate historical record of the clinical trial. This is crucial for regulatory submissions, inspections, and responding to queries from regulatory authorities.

Viedoc TMF

Viedoc TMF is designed for study eTMFs, where each study eTMF is associated with a Viedoc study. Records are encapsulated in a separate eTMF database for each study to maintain the data integrity.

Prerequisites

The following need to be in place in a Viedoc study for users to start using Viedoc TMF:

  • An eTMF license key
  • Study site(s) in production mode
  • A study design that includes enabled clinic roles needs to be applied to the defined production sites.
  • A Viedoc study user needs to be invited to the role eTMF Manager in Viedoc Admin. This role is essential to:
    • Create the eTMF database for the study by enabling the eTMF feature
    • Configure and instantiate the eTMF index to make the eTMF structure available to the users
    • Map the study clinic roles to eTMF roles and permissions to give eTMF access to them

Strengths

This section highlights Viedoc TMF advantages and unique selling points:

  • User management is seamless: Viedoc TMF reuses the user role access to sites defined for Viedoc Clinic, making it effortless for the eTMF Manager to configure access for eTMF users.
  • Site records and documentation (also known as Investigator Site File) can be included in the eTMF: The study eTMF can be scattered across many different systems, for example Outlook, SharePoint, EDC, to name a few. Viedoc TMF makes it easier to maintain one source of truth for the study documentation and eliminates the need for maintaining copies of the records. Data integrity is maintained by simple configuration to user access to access and archive these records.
  • Viedoc TMF is very user-friendly. It is designed and developed with the user in focus to provide a platform that is intuitive to flatten the learning curve.
  • Viedoc TMF follows the industry standards: It supports the TMF Reference Model when it comes to defining the eTMF structure and gives the flexibility of modifying the structure to fit the study needs. It also follows the Exchange Mechanism Standard when it comes to archiving the records.
  • Records in Viedoc TMF (such as study protocols, eConsent documents, and training materials) can be shared with Viedoc and/or Viedoc Me users for information sharing and/or signature collection. Viedoc makes this possible as the eTMF records are maintained within a single system.
  • Viedoc TMF helps the trial staff remain focused on what is important:
    • When users are busy with other activities that generate records that need to be filed in the eTMF, they can drop these records in the drop zone for the drop zone manager or for themselves to do the filing later. This eliminates the risk of forgetting to file essential documentation to the study eTMF and gives the flexibility of dividing tasks between the clinical trial staff.
    • The Details page gives the power of searching and sorting the records according to their data and metadata. This feature brings flexibility for the user to maintain focus on their tasks by easily fetching the records that need their attention in a single view.
    • Viedoc TMF is integrated with the Viedoc suite. This integration eliminates the expensive need for integrating different systems used for a clinical trial and provides efficient workflows and streamlined processes as data flows seamlessly between interconnected systems. It also improves data accuracy and enhances productivity. Viedoc TMF has the same look and feel as other Viedoc suite components, simplifying the training requirements for Viedoc users and making their life easier.
  • Locking the study eTMF is separate from locking the study in Viedoc Admin. As eTMF milestones for a study can be different from the EDC milestones, the flexibility of providing the possibility to collect and analyze the eTMF records after the study lock in Viedoc Admin is important. Our recommendation is to lock the eTMF prior to archiving the eTMF to ensure that no changes can be made to the records while archiving.

Requirements to use Viedoc TMF as an archive TMF

As explained above, there are differences when it comes to the intended use of study and archive eTMFs. If we decide to use Viedoc TMF as an archive TMF, we need to consider the following:

  • Move the archived data away from the production servers to archive servers.
  • Make sure the archived data is available and accessible for the entire retention period, which is at least 25 years after the study completion.
  • Ensure that all Viedoc personnel (Sales, PS, QA, IT) are trained and have competence in selling, supporting, and maintaining the eTMF archive.
  • Functionality to allow searching and sorting of results from multiple studies.

Conclusion

Viedoc has always been study-focused, and that is something that we are experienced in. The requirements for study and archive eTMFs differ, and Viedoc TMF is a study eTMF that is intended to be used during the course of the trial. Should you have any inquiries or need further information, contact us at Product Management or QA, and we will explain more.