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Import TMF files from S3 platform

The eTMF application is a file storage and management system. Therefore, to work with files in eTMF, you need to import them into the system. A file can be imported into the list of essential documents if it contains crucial information related to regulatory and trial compliance. This import is performed with the TMF Import functionality.

The TMF Import functionality helps you retrrieve the required files from two storage options: Amazon S3 (as discussed in the following procedure) or DIA EMS, as discussed in the Import TMF files from DIA EMS section. These two types of file upload are typically used in scenarios where the sponsor switches eTMF system vendors, and the data is taken from the original vendor's system; thus, these data origins may vary.

To import TMF files from the S3 platform

  1. In the eTMF application header, select the TMF tab. On the page that opens, in the left pane, select the Study List subtab.

  2. In the Study List table, next to the needed study, select TMF Import file_icon.png.

    Accessing TLF import
    Figure 1. Accessing TLF import

  3. From the open dropdown menu, select Import from S3.

    Selecting option to import from S3 database
    Figure 2. Selecting option to import from S3 database

  4. On the Import from S3 page, from the workspace toolbar, select New Item add_new_icon.png.

    Accessing option to add new items
    Figure 3. Accessing option to add new items

  5. In the New dialog, specify the details as discussed in the following table.

    Entering import details
    Figure 4. Entering import details

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Import Address*

    Enter the import address provided by the cloud team upon the data manager's request.

    Automatically Parse File Properties

    Use the toggle switch as follows:

    • Leave the toggle turned off to ignore file attributes.

    • Turn on the toggle if you need to populate the file attributes automatically from the S3 bucket to the TMF database.

      Turning on toggle
      Figure 5. Turning on toggle

    File Type*

    From the dropdown menu, select the required file types or clear the unnecessary ones. These file properties are populated from the file type settings.

    Selecting and clearing file types for file import
    Figure 6. Selecting and clearing file types for file import

    The dropdown menu is available only if the Automatically Parse File Properties toggle is turned on.

    SAVE

    Select save_button_red.png to save settings for file import.

    CANCEL

    Select cancel_button.png to cancel configurations and close the dialog without saving.

After saving, the selected file is uploaded from the specified address.

Download S3 file import artifacts

After you have imported the required files from the S3 bucket, you may need to update the file details before further use in the TMF storage. You can update the details by downloading the file as an Excel sheet, editing the details on your computer, and then uploading the file back to the system, using the Download functionality.

To download S3 file import artifacts

  1. In the eTMF application header, select the TMF tab. On the page that opens, in the left pane, select the Study List subtab.

  2. In the Study List table, next to the needed study, select TMF Import file_icon.png.

    Accessing TLF import
    Figure 1. Accessing TLF import

  3. From the open dropdown menu, select Import from S3.

    Selecting option to import from S3 database
    Figure 2. Selecting option to import from S3 database

  4. Now, in the Import from S3 contents panel, next to the imported file you are interested in, select Download download_icon.png to download the file on your computer.

    Downloading file
    Figure 3. Downloading file

  5. The file list you have downloaded consists of two sheets—Index and Detail. In the Detail sheet, configure the attributes as explained in the following table.

    Downloaded file example
    Figure 4. Downloaded file example

    Column

    Details

    Path

    Enter the path to the file.

    File

    Enter the name of the file.

    Zone-Section-Artifact

    Enter the target upload path of the file. For more information about the zone, section, and artifact, refer to the DIA RM version of the TMF base.

    Country

    Specify the country of the file if it belongs to a country-level milestone.

    Site Code

    Specify the site of the file if it belongs to a country-level milestone.

    Document Expiration Date (UTC)

    Specify the expiration date of the file.

    Important

    According to the selected file types, the system will add corresponding customized attributes as columns to the spreadsheet.

    Now, you can upload the updated matching file back to the eTMF app.

Upload matching file back to TMF

After introducing the required changes to the downloaded file (initially imported from the S3 bucket), you can upload it back to TMF. To do this, use the Upload functionality.

To upload a matching file back to TMF

  1. In the eTMF application header, select the TMF tab. On the page that opens, in the left pane, select the Study List subtab.

  2. In the Study List table, next to the needed study, select TMF Import file_icon.png.

    Accessing TLF import
    Figure 1. Accessing TLF import

  3. From the open dropdown menu, select Import from S3.

    Selecting option to import from S3 database
    Figure 2. Selecting option to import from S3 database

  4. In the contents panel, select Upload Matching File upload_icon.png to upload the updated file from your computer.

    Important

    When uploading files from the S3 platform, file name uniqueness is not verified. Therefore, files with identical names are not overwritten.

    If the file list spreadsheet for a study item is reloaded, existing files in the folder are overwritten.

    Accessing option to upload updated file
    Figure 3. Accessing option to upload updated file

  5. After selection, a dialog prompts you that the file will be overwritten. Select OK to confirm your choice.

    Prompting users on files to be overwritten
    Figure 4. Prompting users on files to be overwritten

  6. Follow the prompts of your computer to locate and select the file you have updated and prepared for the upload.

Once uploaded, the system begins validating the file list and generating the upload report. The accountable personnel can directly audit the file imported under the Essential Documents subtab.

If every file’s mapping relation is valid, the item Status in the contents panel is changed from Not start to Success, and the upload is completed. Otherwise, it changes to Failure, and no files are uploaded.

You may troubleshoot the failure by downloading the report after analyzing and resolving it, and then trying to reload the matching file back to TMF.

Download report on S3 file download and upload

You may need to download the report on your computer and upload activities for the specific file to analyze and troubleshoot the issues that might occur during one of the performed actions.

To download a report on the S3 file download and upload

  1. In the eTMF application header, select the TMF tab. On the page that opens, in the left pane, select the Study List subtab.

  2. In the Study List table, next to the needed study, select TMF Import file_icon.png.

    Accessing TLF import
    Figure 1. Accessing TLF import

  3. From the open dropdown menu, select Import from S3.

    Selecting option to import from S3 database
    Figure 2. Selecting option to import from S3 database

  4. In the contents panel, select Download Report download_report_icon.png to upload the report file onto your computer.

    Downloading report
    Figure 3. Downloading report

  5. Follow the prompts of your computer to locate and open the report file. Then, analyze the logs in the file details.

Once analyzed, perform the required troubleshooting. Afterwards, you can try to import the failed file again.

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.