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View artifacts associated with milestone

Milestones are significant events or phases within the lifecycle of a clinical trial that require documentation and tracking. Milestones are configured according to the study plan and protocol, representing key stages of the clinical trial process, such as study initiation, site training, patient enrollment completion, and many others. They are critical for planning, monitoring, and managing the trial progress effectively.

In eTMF, under the Study Tracking page, you can view the list of your study milestones and take a look at all the artifacts that are associated with these milestones. Overall, you associate all your artifacts with milestones or placeholders for better tracking and maintenance.

To view artifacts associated with a milestone

  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. In the Milestone table, go to the needed milestone. Then in the Actions column, select Associated associate_icon.png.

    Accessing option to view associated artifacts
    Figure 3. Accessing option to view associated artifacts

  6. In the Associated dialog that opens, view the list of all the artifacts associated with this milestone. This dialog also displays zones, sections, and the status related to the artifact.

    Analyzinh associated artifacts
    Figure 4. Analyzinh associated artifacts

  7. Select Done_button_red.png to close the dialog.

Once selected, you are back on the Milestone page.

In this section:

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.

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.