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Study dashboards

The Dashboard feature is another TMF option for analyzing study data, including the management of task completion, source file collection, electronic file expiration, artifacts, and other statistics.

Unlike the My Work dashboard, whose study data focuses on the assigned tasks during the study, the Dashboard subtabs provide all study insights.

TMF dashboard menu
Figure 1. TMF dashboard menu

In this section, you can learn about the details and management of the following dashboards:

  • Study Overview: displays insights into the selected study, such as milestones, essential documents, original files, file progress, rejected file records, query status summary, query aging details, artifacts, and more.

  • Process Tracking: displays monthly insights into the milestone and placeholder management in the selected study at the study, country, and site levels, such as completion rate, overdue statistics, planned milestones, and more.

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.

In eTMF, the lowest level of the file directory predefined by the Drug Information Association Reference Model (DIA RM). Artifact-level folders exist within a section and store individual documents—the actual files related to the clinical trial that are stored in the eTMF system.

Artifacts could include files of regulatory submissions, consent forms, clinical trial protocols, or monitoring visit reports.

CRF