Milestone setting

Add milestone setting

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

During the study, you accumulate documents of various types. By associating milestones with documents, you can measure the completion of study processes and landmarks by tracking the status of the documents about them.

There are multiple ways of adding new milestone settings to the eTMF application:

To add a new milestone setting

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the page that opens, in the workspace toolbar above the Milestone table, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page that opens, from the workspace toolbar, select New .

Figure 4. Accessing option to add new milestone

In the New dialog, enter the milestone information as explained in the following table.

Figure 5. Adding new milestone

Tip

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

Element	Details
Milestone#*	Enter the milestone number for which you want to create the setting.
Milestone*	Enter the name of the milestone that corresponds to the selected milestone number.
Level	From the dropdown list, select the desired levels at which you want to configure the milestone (that is, study, country, or site).
SAVE	Select to implement the changes.
CANCEL	Select to dismiss the implemented changes without saving.

Upon saving, the new milestone setting is added and displayed in the Milestone Setting page.

Edit milestone setting

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

The Milestone Setting page represents the list of configurations created for the existing milestones. Here, you can change the milestone number, value, and its level.

To edit the milestone setting

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the page that opens, in the workspace toolbar above the Milestone table, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page that opens, locate the milestone setting that you want to update, and then in the Action(s) column, select Edit .

Figure 4. Accessing option to edit milestone details
In the Edit dialog that opens, edit the necessary information as needed. The fields are identical to the ones explained in the table of the Add milestone setting section.

Figure 5. Editing milestone details

Upon saving, the milestone setting is updated.

Associate artifact with milestone

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

Associating specific artifacts with predefined milestones helps create a clear structure within the eTMF. This association aids in the review and approval process, as stakeholders can quickly find all necessary documentation associated with each milestone.

To associate artifacts with the milestone

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page, next to the needed milestone, select Associate .

Figure 4. Accessing option to associate artifact with milestone
In the Associate Artifact dialog, choose the desired level at which you want to associate the artifacts, and then next to the artifacts, clear or select the checkboxes to remove or create an association with the selected milestone.

Figure 5. Associating artifacts
Select to apply the changes.

Upon saving, the artifacts' association with the milestone is completed.

Download milestone setting template

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

The Download Milestone Settings functionality is quite useful when you need to introduce many changes to the settings at once.

To download the milestone setting template

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page that opens, from the workspace toolbar, select Download Template .

Figure 4. Downloading milestone setting template

Upon saving, the XLSX template file is downloaded to your computer. Now you can fill it out with data—create the milestone list—and then import the file back to generate the milestone list in the eTMF system.

View milestone setting audit trail

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

The audit trail data in eTMF serves as a comprehensive record that tracks changes made to the milestone settings, including additions and modifications.

To view the milestone setting audit trail

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
In the Milestone Setting table, go to the needed milestone setting. Next to the required milestone, in the Actions column, select Audit Trail .

Figure 4. Accessing option view milestone setting's audit trail
In the Audit Trail dialog that appears, you can view the log of operations performed on the milestone setting.

Figure 5. Analyzing audit trail of milestone settings
Select to close the dialog.

Once done, you return to the Milestone Setting table.

Import milestone setting list

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

After you have downloaded the template file, updated it with the required settings, you may want to introduce these changes in eTMF by importing the XLSX file back. It is very useful if you need to make multiple changes at once.

To import the milestone setting list

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page that opens, from the workspace toolbar, select Import .

Figure 4. Importing milestone list

Upon importing, the system generates the milestone list for the study based on the data from your XLSX spreadsheet.

Export milestone setting list

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

In the eTMF application, you can export the milestone settings for a particular study to work with them offline and import them back into eTMF. With this functionality, you can update the existing milestones in bulk instead of editing them one by one.

To export the milestone setting list

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page that opens, from the workspace toolbar, select Export .

Figure 4. Exporting milestone setting

Once exported, the file is saved on your system in the XLSX format. You can now work with it offline.

Delete milestone setting

Milestone settings are configurations that create the framework for how milestones are utilized within the trial at the study, country, and site levels. These settings ensure that milestones are tailored to the specific needs of the study and provide the structure for tracking and managing those milestones effectively.

If the milestone settings contain errors or have become obsolete, it may be necessary to delete the redundant entry to keep the list of milestones up-to-date. Furthermore, some milestone settings related to canceled trials or phases that will no longer take place may need to be removed to maintain focus on current and relevant activities.

To delete a milestone setting

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

Figure 1. Selecting study
On the page that opens, select the Study Tracking pane option.

Figure 2. Accessing study tracking page
On the Milestone page that opens, from the workspace toolbar, select Setting .

Figure 3. Accessing study tracking and milestone setting
On the Milestone Setting page, select the checkboxes next to the milestone settings you want to delete, and from the workspace toolbar, select Delete .

Figure 4. Deleting milestone
In the Delete confirmation dialog that opens, select to remove the selected settings.

Figure 5. Confirming milestone deletion