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View valid file statistics

In eTMF, the Valid File Statistics report provides easy access to files that are considered valid in the system, meaning that they have received their final approval after the proper audit. The files in the report are divided by their zone, section, and artifact, and then by levels (study, country, or site), versions (master or appended), and finalization status. This gives you easy access to specific file groups for detailed analysis.

For instance, using this report, you can access all master files of the Financial Disclosure Summary artifact-level directory and review their details via the File Detail Sheet report in one click.

Example of accessing all master files of artifact-level directory
Figure 1. Example of accessing all master files of artifact-level directory

Important

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

The report does not include replaced, expired, or dropped (failed auditing) files.

To view the valid file statistics report

  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 Valid File Statistics.

    Accessing valid file statistics
    Figure 2. Accessing valid file statistics

  3. In the Valid File Statistics table that opens, view details of statistics of valid files in the following table.

    Viewing valid file statistics
    Figure 3. Viewing valid file statistics

    Tip

    From the DIA RM Version dropdown menu on the workspace toolbar, select the version of the Drug Information Association Reference Model for the Valid 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 the 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 Master Files

    Represents the number of files that are from the master file group. The master file is the first file uploaded to the main repository that can be later appended with supplementary documents providing additional information or supporting the master file.

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

    # of Append Files

    Represents the number of files that are from the append file group. Appended files are supplementary documents added to the system to provide additional information or support the master file.

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

    # of Study Level Files

    Represents the number of files that are from the study level—containing information necessary for all study participants, regardless of their country or site of location.

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

    # of Country/Region Level Files

    Represents the number of files from the country or region level, containing information necessary for all study participants within a specific country or region, regardless of the site to which they belong.

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

    # of Site Level Files

    Represents the number of files from the site level—containing information necessary for all study participants that belong to the specific site.

    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 number of files with the status Final—the files that have received 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.

You have viewed the valid 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.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

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.