Skip to main content

View file detail sheet report

In eTMF, the File Detail Sheet subtab shows all the master and appended files with their basic attributes.

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, which are respectively called appended files.

Important

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

The report does not include replaced files.

To view the file detail sheet 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 File Detail Sheet.

    Accessing file detail sheet report
    Figure 1. Accessing file detail sheet report

  3. In the File Detail Sheet table that opens, the details master and appended files and their basic attributes are explained in the following table.

    Viewing file details
    Figure 2. Viewing file 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 File Detail Sheet 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.

    Document ID

    Represents the unique identifier assigned by the system to the file upon upload to eTMF for tracking purposes.

    Standard File Name

    Represents the standard name of the file—the one assigned to the file upon upload to eTMF. The standard file name can differ from its original name for compliance reasons.

    Original File Name

    Represents the original name of the file—the name it had before being uploaded to eTMF and receiving the standard file name.

    Level

    Represents the level at which the files and their attributes are available—study, country, or site.

    Country/Region

    Represents the name of the country to which the file belongs. This value is only available for country- and site-level files, and for study-level ones remains blank.

    Site Code

    Represents the code of the site to which the file belongs. This value is only available for site-level files, and for study and country-level ones, it remains blank.

    Document Expiration Date(UTC)

    Represents the expiration date of the file.

    Master File or Append File

    Specifies whether the file is a master or an append one.

    Master File Name

    Represents the name of the master file to which the appended file belongs. This value is only available for appended files, and for the master ones remains blank.

    File Type

    Represents the custom type of the file, if any.

    Status

    Represents the status of the file—Dropped, Final, Auditing, and so on.

    Author

    Represents the name of the user who created the file.

    Modify Time

    Represents the time when the file was last modified.

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

In this section:

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.

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.