Skip to main content

Analyze essential documents

In the eTMF application, the Essential Documents page represents file storage based on the DIA TMF reference model. It contains specific files required for compliance and regulatory purposes. These files are used for planning and integrity purposes, for example, a file that includes the detailed plan of the eClinical trial, along with modifications made to the original protocol.

Important

To manage TMF files on the Essential Documents page, ensure that all of them are imported from S3 or DIA EMS and structured as per DIA RM.

To analyze essential documents

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

  2. On the page that opens, in the left pane, select the Study List subtab.

  3. In the Study List table, select the study for which you want to access the relevant files and documents.

    Selecting study
    Figure 1. Selecting study

  4. On the page that opens, in the left pane, select the Essential Documents subtab.

    Accessing essential documents
    Figure 2. Accessing essential documents

  5. On the Essential Documents page that appears, view the details of various elements as explained in the following table.

    Essential documents storage UI structure
    Figure 3. Essential documents storage UI structure

    Element

    Details

    Explorer tree pane

    Represents the explorer tree of directories structured according to the DIA RM version specified at the stage of the TMF base creation. Next to each directory, the total number of files within (based on the selected level) is indicated in brackets.

    You can perform the following actions from the explorer tree pane:

    • Switch View sideways_arrows_icon.png: select this icon to switch between DIA RM and the custom mode.

    • Collapse All Collapse_All_icon_.png: select this icon to minimize or all expanded directories.

    • Refresh refresh_icon.png: select to refresh the directories.

    Workspace Toolbar

    For more information about the Essential Documents page workspace toolbar, refer to the Contents panel section.

    From the toolbar with the Filter filters_icon.png condition, you can apply filters to search for the desired record. These filter conditions remain on the File List table even if you leave the page or log out of the eClinical account.

    Contents panel

    For more information about the Essential Documents page contents panel, refer to the Contents panel section.

    Study menu

    Represents the name of the study for which you are viewing the relevant files and documents.

    Level menu

    Represents the level of the study for which you are viewing the relevant files and documents, such as Study Level, Country Level, and Site Level.

    Based on the currently selected level, the total number of files is displayed next to the directories of the explorer tree pane. If the study level is selected, the number of files in brackets next to the directory means only the number of study-level files; if the country or site level is selected, then the number indicates only country- or site-level files.

    Country menu

    Represents the name of the country for which you are viewing the relevant files and documents.

    This menu becomes available if, in the level menu, Country Level is selected.

    Site menu

    Represents the unique identifier of the site for which you are viewing the relevant files and documents.

    This menu becomes available if, in the level menu, Site Level is selected.

  6. In the File List table of the contents panel, the files have their respective properties, as explained in the following table.

    File list of essential documents
    Figure 4. File list of essential documents

    Tip

    The available columns for file properties may vary based on the custom file type configurations of your study.

    Column

    Details

    Document ID

    Represents the unique identification assigned to the file upon uploading to the eTMF system for tracking purposes.

    Standard File Name

    Represents the name of the file under which it is currently available in the eTMF system.

    Original File Name

    Represents the file's primary name before it was changed upon upload to the eTMF system or further file amendments.

    Author Name

    Represents the first and last name of the user, as specified in user information in ADMIN, who is associated with the file as its owner in eTMF.

    Author Account

    Represents the login name of the user account, as specified in user information in ADMIN, which is associated with the file as its owner in eTMF.

    File Uploaded Time (UTC)

    Represents the date and time when the file was uploaded to the essential documents.

    Modify Time

    Represents the exact date, time, and time zone indicator of when the latest modification was made to the file.

    Version

    Represents the current version number of the file. File version changes upon appending or replacing.

    # of Append Files

    Represents the number of supplementary documents that are currently appended to the original (master) file.

    File Size (KB)

    Represents the size of the file to give you an understanding of how much storage space it takes in eTMF or might take on your computer upon download.

    Status

    Represents the current auditing status of the file—Auditing, Rejected, Final, or Dropped.

    File Path

    Represents the complete path to the directory where the file resides, helping you to locate the document.

    Level

    Represents the level at which the file is available. It can be a country, a site, or a study.

    For instance, the files "Investigator Brochure" differ for the U.S. and European Union, so each such file you upload can be associated with the specific country or region, thus making it a country-level file.

    Or if the files are the licenses of the specific sites' principal investigator (PI), each is associated with the specific site, thus making them the site-level files.

    Country / Region Name

    Represents the name of the country or region to which the file relates. This value is only available for the country- and site-level files.

    Site Code

    Represents the unique identifiers of the site to which the file relates. This value is only available for the site-level files.

    Site Phase

    Represents the current phase of the site set via the CTMS application.

    Document Expiration Date

    Represents the date when the file becomes outdated and must be replaced with a newer version or otherwise addressed.

    Zone

    Represents the zone-level directory to which the file belongs.

    Section

    Represents the section-level directory to which the file belongs.

    Artifact

    Represents the artifact-level directory to which the file belongs.

    Artifact #

    Represents the number of the artifact-level directory to which the file belongs.

    Placeholder

    Represents a title and link to the relevant placeholder document associated with the specific file.

    Original Document Needed

    Represents whether the original (source) document collection is obligatory (Yes) or optional (No) for the file.

    Original Document Received

    Represents whether the original (source) document is already collected (Yes) or not (No).

    File Description

    Represents any auxiliary details added to the file by the user upon uploading it to eTMF.

    File Type

    Represents the custom file type configured in eTMF to help distinguish your study documents according to their purpose and business value.

After you have analyzed the details of the files of interest via the Essential Documents storage, you can manage your essential documents at different levels that represent study containers, the folders inside the study containers, and the files inside these folders:

See also
In this section:

A model for organizations from DIA that provides a standard taxonomy and metadata of TMF content.

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.

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 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 instance created in eTMF in place of a source file that has not yet been uploaded to the system (for example, has not yet been collected or completed).

Placeholders are a helpful tool in the process of filling out the Trial Master File (TMF). With the placeholders, you preserve the eTMF integrity until the source files become available.

PI