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Settings for new studies in TMF base

In eTMF, the system automatically adds new studies to the Study List page after they are created in CTMS. When the new study appears in the list, it is empty, and you need to configure its TMF base manually to complete the study initialization in the eTMF system.

A TMF base study represents the foundational structure or framework used within eTMF and serves as a centralized location for all trial-related documents, such as essential documentation and records related to clinical trials, making it easier for teams to access, manage, and share information.

Viewing new study in study list
Figure 1. Viewing new study in study list

In the eTMF application, you can select to use one of the available structures for your TMF base as discussed in the following sections.

In this section:

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

Get to know all the possibilities of the app with the comprehensive CTMS User Guide.

A compilation of documents proving that the study is held following regulatory requirements. The TMF is a crucial part of ensuring the trial is successfully managed by all the involved parties.