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Edit artifact

Artifacts are records, documents, or files containing any information that is captured during a clinical trial and that meet the purpose or definition described in the DIA RM. In some cases, the artifact is a single document, dataset, or piece of information, but in other cases, it can be represented by multiple document types or data types. These artifacts are stored in the respective folders of your study in Essential Documents.

In eTMF, you can manually update the status of your artifacts to reflect their current processing condition. To make the status update accountable, you have to provide the reason for every such change.

To edit an artifact

  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 needed study name.

    Selecting study
    Figure 1. Selecting study

  4. On the page that opens, select the Study Tracking pane option.

    Accessing study tracking page
    Figure 2. Accessing study tracking page

  5. On the page that opens, in the table, select the Artifact tab and locate the artifact that you want to edit. Then from the Action(s) column, select Edit pencil_icon.png.

    Accessing option to edit artifact
    Figure 3. Accessing option to edit artifact

  6. In the Edit dialog that appears, edit the fields as explained in the following table.

    Editing artifact
    Figure 4. Editing artifact

    Element

    Details

    Status*

    From the dropdown menu, modify the status of the artifact to either of the following:

    • Not started: the artifact has not been started yet. This status indicates that the document is in the early stages before it can move to the processing status.

    • Processing: the artifact is currently being actively worked on. This status indicates that the document is in the midst of creation, review, or any other operational activity that is necessary before it can move to the completion status.

    • Completed: the artifact has been finalized, and all necessary actions or processes associated with it have been completed. It is now considered finished and not intended for further changes unless a review triggers another action.

    Comment*

    Enter any additional comments to support the status change.

    SAVE

    Select save_button_white_red.png to implement the changes.

    CANCEL

    Select cancel_button_black_white.png to dismiss the changes without saving.

Upon saving, the artifact is updated.

In this section:

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.