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TMF

Trial Master File (TMF) is 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.

In the eTMF application, the TMF tab is designed for the management of essential documents in clinical trials. Under this tab, you can manage files according to DIA reference model in the unit of studies.

TMF page and subtabs
Figure 1. TMF page and subtabs

The TMF tab comprises the following subtabs.

Subtab

Details

Study List

Manage the studies available in the eTMF system as well as access the study dashboards, Essential Documents, Document Warehouse, Intelligent Upload, Study Tracking, and Study Details pages.

File Type Setting

Create customized file types to expand the configurable attributes of files.

File Task

View all files to be audited in the Essential Documents directories and perform the audit.

Query Task

View all the queries created for files under the FILE MANAGEMENT and TMF tabs waiting to be answered or resolved.

File Trash

View all the files deleted from the Essential Documents directories, restore them, or delete them permanently.
In this section:

A type of documentation in the clinical trial that permits the quality evaluation of the clinical trial's conduct to ensure that the collected data is credible and the participants' trial rights and well-being are protected.

These documents include: Trial Protocol and Amendments, Investigator’s Brochure (IB), Informed Consent Form (ICF) and any updates, Ethics Committee (EC)/Institutional Review Board (IRB) Approval, Curriculum Vitae (CVs) of Investigators, Clinical Trial Agreement, Financial Disclosure Forms, Insurance Statement, Regulatory Authority Authorization, and Laboratory Certification/Norms.

A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.

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