Summary

This article covers the contents of the site milestone's form.  

Table of Contents

• Access Site Milestones Form
• Site Milestone Table
  • Milestone Column
  • Targeted Date
  • Projected Date
  • Actual Date
  • Comment

Each Study Site contains a Site Milestones form. The Site Milestones defined at the Clinical Plans level will appear on the Study Site Milestones form. At the site level the milestone name, milestone type and dependency settings cannot be changed. While the form found in Clinical Plans was used to configure these milestones, at the site level, data collection is enabled. Targeted Dates for each site milestone expecting one will need to be defined for dependent dates and projected dates to be calculated.

Access Site Milestones Form

The Site Milestones form for each site can be accessed under each Study Site Name.

Site Milestone Table

The Site Milestone Table will display all Site Milestones defined in Clinical Plans.

The Milestone table includes the following columns:

Milestone Column

Milestone columns will include the name of the milestone and icons:

• Edit Icon – when selected the Edit Study Milestone dialog will appear.
• Audit Icon – when selected the audit table for the site milestone will appear.

Targeted Date

The Target Date is the baseline date for the site milestone. The Targeted Date is manually defined for Specified Date and EDC Events on the Edit Milestone screen. The Target date for Dependent Milestones calculates it’s Targeted Date based on its dependency relationship.

• The Target Date will add the offset days defined for the milestones.

Projected Date

The Projected Date will project the expected date of the milestones. If dependent milestones contain an Actual date, the projected date will use the actual date as the calculation. If the dependent date does not have an actual date the projected date for the dependent milestone will be used.

• The Projected Date will add the offset days defined for the milestones.

When a user hovers their mouse over the projected date a pop-up will appear and show the settings for the calculation, including any offset days.

The Projected Date can be updated by selecting the Update Icon beside the Projected Date. The Change Projected Date screen will appear to provide the updated projected date.

Note: If a Milestone has a projected date that was calculated using a dependency and the projected date is manually updated, the calculation will be overridden and will no longer be used to populate the projected value. Additionally all milestones that were dependent upon the projected date of the updated milestone will be automatically recalculated by the system to reflect this new value.

Actual Date

The Actual Date will provide the date the milestone was achieved. For EDC Event milestones the Actual Date is auto-populated based on the data in the EDC for the individual site. For Specified and Dependent Date the actual date must be provided through the Update Icon in the Actual Date column. The Milestone is Complete screen will appear to provide the actual date.

Comment

The Comment column displays comments made by users with editing access to milestones. The comments can be viewed by all users with access to this screen. Clicking the Comment column Update icon allows users with editing access to document/edit a comment. Comment activity is captured in the milestone’s audit trail and in the Question Audit Manager.

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