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View expired file list

In eTMF, the Expired File List report shows the expired files and their basic information and indicates whether the alert email for the file has been sent to notify the interested parties of its expiration.

The files that have a certain expiration period must be updated in eTMF with the newest version to have valid documents to support your study for auditing and compliance purposes. Tracking the report on expired files can help you detect and act on such documents.

An example of an expired file can be a copy of the principal investigator's license certificate that has a validity period and must be renewed afterward.

Important

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

The report does not include replaced and dropped (failed auditing) files.

To view the expired file list

  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 Expired File List.

    Accessing expired file list
    Figure 1. Accessing expired file list

  3. In the Expired File List table that opens, view the basic information of expired files as explained in the following table.

    Viewing expired file list
    Figure 2. Viewing expired file list

    Tip

    From the DIA RM Version dropdown menu on the workspace toolbar, select the version of the Drug Information Association Reference Model (DIA RM) for the Expired File List 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.

    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.

    DIA RM Version

    Represents the version of the DIA RM according to which this file is uploaded and classified to a certain directory of Essential Documents.

    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.

    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.

    Sent Alert Email

    Specifies if the alert email about the file expiration has been sent (Yes) or not (No).

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

In this section:

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.

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.