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View total file statistics

The Total File Statistics report shows the total number of files in eTMF in their various statuses—Dropped, Final, and In Progress—and for each study, zone, section, and artifact.

Important

To view this report, you must have the Total File Statistics permission granted to your user role, via the ADMIN application.

To view the total file statistics

  1. In the eTMF application header, select the REPORT tab.

  2. On the page that opens, in the left pane, expand TMF Report and select Total File Statistics.

    Accessing total file statistics
    Figure 1. Accessing total file statistics

  3. In the Total File Statistics table that opens, view details of the statistics of the total number of files in eTMF in the following table.

    Viewing total file statistics details
    Figure 2. Viewing total file statistics details

    Tip

    From the DIA RM Version dropdown menu on the workspace toolbar, select the version of the Drug Information Association Reference Model for the Total File Statistics report to only display the files that belong to that version.

    Column

    Details

    Study Name

    Represents the name of the study to which the file belongs.

    Zone

    Represents the zone to which the file belongs in the Essential Documents storage.

    Section

    Represents the section to which the file belongs in the Essential Documents storage.

    Artifact

    Represents the artifact to which the file belongs in the Essential Documents storage.

    Total # of Files

    Represents the total number of files under a specific artifact.

    The value is also a hyperlink that, once selected, redirects you to the File Detail Sheet report filtered according to your selection.

    # of Dropped Files

    Represents the total number of files whose status is Dropped—the file has not passed the final audit.

    The value is also a hyperlink that, once selected, redirects you to the File Detail Sheet report filtered according to your selection.

    # of Final Files

    Represents the total number of files whose status is Final—the file has received its final approval or signature by the respective auditors.

    The value is also a hyperlink that, once selected, redirects you to the File Detail Sheet report filtered according to your selection.

    # of Auditing Files

    Represents the total number of files whose status is Auditing. These are the files that are awaiting approval or are approved—the intended operation with the file is in the process of auditing.

    The value is also a hyperlink that, once selected, redirects you to the File Detail Sheet report filtered according to your selection.

You have viewed the total file statistics report. You can also export the report data to work with it offline.

In this section:

In eTMF, a highest level directory within the file storage organized according to the Drug Information Association Reference Model (DIA RM). Zones are typically used to categorize documents by their role or type within the clinical trial. The zone helps with the general document grouping that may later be subdivided into specific sections and artifacts.

Zones can represent large groups of documents such as regulatory documents, study documentation, clinical trial agreements, and so on.

In eTMF, a level of the file directory predefined by the Drug Information Association Reference Model (DIA RM). Sections are grouped within zones and help divide the documents of the zone into more specific categories. Each section defines a group of documents that share a similar purpose or function within the clinical trial.

For example, within the regulatory zone, sections might include ethical approvals, investigator brochures, or site contracts.

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.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.

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.